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Historically, vaccines are medicines that deliver or generate antigens that induce specic, active, and protective immunity against infectious diseases. Antigens stimulate the immune system to activate cells and organs that induce active immunity, characterized by production of antibodies (humoral immunity) and/or cytotoxic T-cells (cell mediated immunity). Vaccines “train” the body’s immune system to ght infection or disease. Vaccines have eradicated smallpox, practically eliminated polio, and ...
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Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug is on the critical path toward clinical phase 1 dosing and safety studies as well as ...
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Outsourcing is one of the commonly used approaches by pharmaceutical companies. Increasingly, pharma and biotech firms are searching for new drivers of revenue and profit growth. There are a number of trends and forces within the pharmaceutical industry that are causing companies to rethink their approaches to growth and cost management.
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The enormous advances in biological technology over the past four decades have led to a profound change in how information is processed; conceptual and technical developments in experimental and molecular biology disciplines such as genomics, transcriptomics, proteomics, metabolomics, immunomics, and countless other "omics" have resulted in a veritable sea of data with the potential to radically alter biomedicine. The discipline of bioinformatics has emerged to capture the information stored ...
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If designing and implementing processes that are efficient, successful and adaptable is an art, conforming to these processes to rigorous U.S. Government acquisition requirements is a science. While these points may appear deceptively simple, it has taken the combined effort of dozens of dedicated team members--from both government and industry--to arrive at these "a-ha" moments.
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Gretchen Stup of DVC and Kevin Raum of Coridium Advisors presented an online webinar to project managers to discuss the tools to identify, assess, mitigate, prepare for, track, and communicate project and program risks on March 11, 2010.
DVC and Coridium Advisors developed this presentation to:
- Share our experiences and lessons from the successful implementation and application of a risk management framework
- Provide an overview of the basic principles of Risk Management
- Provide ...
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Earned value management integrates scope, cost and schedule into a methodology for maintaining a budget with any project. Government agencies increasingly require a validated EVMS system for financial reporting. DVC’s Earned Value Manager, Ida Davis provides an overview of EVM for government contracting.
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Biotech was “born” in the 1970s. Since that time innovation by biotech pioneers has brought more than 200 medicines and vaccines to fruition for difficult-to-treat indications including oncology, HIV/ AIDs, diabetes, and immune disorders.
Biotech is poised to capitalize on the current challenges confronting Big Pharma: looming patent expirations on blockbuster medicines and a dearth of new compounds in the pipeline to replace them. Current pharmaceutical business models are in the doldrums ...
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Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success.
A biopharmaceutical formulation consists of active pharmaceutical ingredient and other ingredients that help maintain the drug product's chemical, biochemical, and physical ...
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Boosting Patient Recruitment in Oncology Trials A CEE of Opportunity
Boosting Patient Recruitment in Oncology Trials A CEE of Opportunity
Averion International Corp. is an international CRO with extensive experience in designing and conducting complex multi-center international oncology trials. Over the past 25 years, we have conducted over 200 oncology studies in 43 countries ranging from Phase I to Phase IV and involving more than 25,000 patients in over 2000 sites throughout the USA, ...
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In recent years the pharmaceutical industry has declined in performance (1), with replenishment of the product pipeline becoming the main criterion for drug discovery research transformation. With US$ 60bn worth of products going off patent by 2011, life science companies must identify novel and innovative methods to compensate for falling research productivity (2). According to Jean-Pierre Garnier, CEO GSK, “broad transformations of the organization are necessary first steps…only the very best ...
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Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In addition, increased scientific and agency scrutiny pertaining to the bioanalytical method validation ...
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The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the 1920s. A new study published by a market research firm reports that 2006 revenues for the total ...
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In March 2006, six normal healthy volunteers participating in a clinical study in the UK were given an intravenous (IV) dose of an experimental immuno therapeutic as a part of an ascending single dose safety and tolerability study. Within a few hours of drug administration, all subjects exhibited severe reactions which progressed to multiple organ failure. As a result of the incident, regulatory agencies began extensive review of First In Human (FIH) studies and the UK’s Secretary of State for ...
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The ability to respond to ever-evolving consumer at- titudes, regulatory mandates, and scientic discov- eries requires that manufacturers keep their nger on the pulse of the analytical methodologies required to monitor product safety and quality. In light of the ever- growing number of food and supplement ingredients and complex formulations, the ability to detect unique com- pounds and quantify levels of ingredients at trace levels presents challenges to researchers. The increased efciency and ...
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There is a growing body of evidence to suggest that the autoimmunity observed in type 1 diabetes mellitus (T1DM) is the result of an imbalance between autoaggressive and regulatory cell subsets. Therapeutics that supplement or enhance the existing regulatory subset are therefore a much sought after goal in this indication. Here, we report the results of a double blind, placebo controlled, phase I clinical trial of a novel antigen-specic therapeutic in 12 subjects with recently diagnosed T1DM. ...
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How to Guide for Writing a Drug Master File Introduction A drug master file (DMF) is a proprietary document typically written by or for the manufacturer to protect manufacturing information, an intermediate, starting raw material, Active Pharmaceutical Ingredient (API), description of production site/s or for other special requests. Most often, DMF's are written to protect the manufacturing information of an intermediate or API. However, many countries require a Site Master File (SMF). ...
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A Q&A with AstraZeneca CEO David Brennan where he reveals the future of his company, what he's learned on his recent travels, and how the pharma industry must change.
What trends are you seeing in the pharma marketplace as a result of the economic crisis? How is this impacting the debate on health reform in the United States? The pharmaceutical industry is not as exposed to the boom and bust cycles that affect other sectors. So, while we are not immune to economic downturn, we are likely to ...
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For 2009, the World Health Organization cited confirmed cases of the H1N1 virus in more than 208 countries, including at least 13,554 deaths. As such, an influenza pandemic poses real threats to disrupt clinical trials. For example, what if half an entire project team were unable to work or participate in a clinical trial for upwards of two to four weeks? Jeff A Kueffer, VP for Global Operations Management at INC Research, Inc. discusses mitigating such risks.
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The risk of virus contamination is a feature common to all biotechnology products produced from animal or human sources. Contamination can arise from a source cell line or from adventitious virus introduced during production. The approach to ensuring viral safety includes several complementary approaches, which are laid out in guidelines from the FDA, EMEA and ICH (references 1-4). These guidelines address the viral safety testing requirements for applications for marketing authorization. A ...
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Single-use, disposable products were first introduced to the biomanufacturing industry about a decade ago. Until recently, single-use manufacturers had to extol their benefits and virtues to convince biomanufacturers to consider trying them. However, today’s growing biopharmaceutical product diversity, increasing demand, and high development costs are forcing an increasing number of life sciences companies to incorporate single-use, disposable technologies into their biomanufacturing
production ...
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Introduction Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS). MS is one of the most common disabling neurological diseases in young adults. The main characteristics of this disease are focal areas of demyelination and inflammation, however, the pathogenesis is unclear.The disease course is unpredictable and life-long, and affects women more commonly for unknown reasons. The etiology of the disease seems to be dependent on genetic and environmental factors. ...
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The feasibility of reversing human aging within a matter of decades has traditionally been dismissed by all profes- sional biogerontologists, on the grounds that not only is aging still poorly understood, but also many of those aspects that we do understand are not reversible by any current or foreseeable therapeutic regimen. This broad consensus has recently been challenged by the publica- tion, by five respected experimentalists in diverse sub- fields of biogerontology together with three of ...
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Analytical characterization of purified proteins, in particular recombinant proteins for drug discovery and development, requires confirmation of the full length protein sequence. Here we present a powerful mass spectrometry method (MALDI ISD) that provides partial sequence information of the intact protein with up to 20-50 amino acid residues from both the N-terminal and C-terminal in one single analysis. The analysis can thus confirm expression and purification of the full length protein ...
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The U.S. Orphan Drug Act was signed into law in 1983 and for the first time, provided incentives for the pharmaceutical industry to develop drugs that otherwise had minimal commercial return on investment, but which are necessary, and often life-saving, for patients with rare diseases. The Orphan Drug Act is codified in 21 CFR Part 316.
There are approximately 6000 rare disorders affecting approximately 25 million Americans. More importantly, of these rare disorders, approximately 85 are ...
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The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, concluded that the science of drug safety needed major improvements. Recommendations included a ...
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The purpose of this document is to recommend international standards for and to promote harmonization of the nonclinical safety studies needed to support human clinical trials of a given scope and duration. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist between regions. This guidance should facilitate the timely conduct of clinical trials and reduce the unnecessary use ...
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Women of childbearing age are susceptible to a wide range of medical conditions that require chronic therapy such as diabetes, depression, epilepsy and asthma. If they become pregnant, they must also face questions regarding the po- tential impact of their medication on the risk of birth defects. Those who seek materials regarding the potential effect of medications on risk of malformation are often disappointed by the lack of specific information available in most product labels and from ...
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The Netherlands offers pharmaceutical firms a favorable environment for receiving expedited study review. Clinical studies can be rapidly initiated in The Netherlands due to Dutch government regulations for clinical research. Based on years of experience operating in the Netherlands, this whitepaper will:
- Outline the regulatory guidelines for studies in The Netherlands.
- Highlight advantages for sponsors conducting studies in The Netherlands.
- Provide details on how to appropriately ...
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SeaSonality:the CliniCal trial Manager’S logiStiCal Challenge
Written by Yamin Khan, PhD and Sarah Tilly
1. IntroductIon Seasonalvariationintheincidenceofdisease shasbeen observed for centuries, dating back at least to ancient Greece, and yet scientific understanding of its under‑ lying mechanisms remains relatively rudimentary for many diseases.1 Seasonality is not only an important factor in common infectious diseases (such as influen‑ za, chickenpox and measles) but also in non‑infectious ...
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The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced by the FDA, which focuses on an integrated approach of good science and good engineering practices ...
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This paper explores the opportunities to improve the R&D process. It proposes new technologies will enable the adoption of virtual R&D; and by operating in a more connected world, the industry in collaboration with researchers, governments, healthcare payers and providers, can address the changing needs of society more effectively.
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All PharmaTech Whitepapers
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In the regulated life sciences industry failure to meet expectations can not only bring down reprimands from senior management, who themselves are often complicit in the failure, but also can evoke the “attention” of the FDA or other international regulatory agencies. Fortunately there are 10 simple tips to follow for a successful CMMS or EAM system implementation.
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17 Rules of the Road for CRM Sage CRM Solutions
17 Rules of the Road for Customer Relationship Management
When it comes to choosing the right customer relationship management (CRM) system for your business, it’s important to understand all the benefits of an integrated CRM system before beginning your selection process.
When you launch a CRM implementation, your choices can impact nearly everyone in your company. That’s why we’ve created this booklet. These 17 “rules of the road” for CRM ...
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3rd Millennium, Inc. www.3rdmill.com 391 Totten Pond Road, Ste. 104 Waltham, MA 02451 781-890-4440
Challenges.............................. ........................................ ........................................ ......................... 4 Semantic data integration............................. ........................................ ........................................ .. 7 Data integration technologies............................ ........................................ ...
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3rd Millennium, Inc. www.3rdmill.com 391 Totten Pond Road, Ste. 104 Waltham, MA 02451 781-890-4440
Knowledge Management in Drug Discovery R&D
Roland Carel, Ph.D.1 and Jack Pollard, Ph.D.1 3rd Millennium Inc.
“Each problem that I solved became a rule, which served afterwards to solve other problems.” René Descartes in Discours de la Méthode
The pharmaceutical industry has created value primarily by generating and assembling information into knowledge applicable to human health. Recent ...
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Potent compounds: 7 things that every pharmaceutical environmental, health and safety professional should know by Dean M. Calhoun, CIH, President and CEO, Affygility Solutions, LLC, Broomfield, Colorado
Occupational exposures to potent compounds must be managed Unlike traditional hazardous substances, active pharmaceutical ingredients (API) are designed to have an effect on the human body. As stated by Dr. Joe Nieusma, Senior Occupational Toxicologist for Affygility Solutions, “If an
operator ...
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Apomorphine is under investigation for the treatment of erectile dysfunction.The enterohepatic recirculation of [14C]apomorphine in Sprague-Dawley rat was investigated. Bile duct-cannulated rats (1M, 1F) were administered a single subcutaneous injection of [14C]apomorphine HCl in saline (containing 1% ascorbic acid and 0.05% sodium metabisulfite) at 2.73 mg free base/kg body weight (90 µCi/kg).The radioactivity recovered in various samples collected totaled 81.86% of dose. Metabolites were ...
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High-throughput and virtual screening are widely used to discover novel leads for drug design. On examination, many screening hits appear non-drug-like: they act noncompetitively, show little relationship between structure and activity, and have poor selectivity. Attempts to develop these peculiar molecules into viable leads are often futile, and much time can be wasted on the characterization of these “phony” hits. Despite their common occurrence, the mechanism of action of these promiscuous ...
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By Bruce B. Weiner Ph.D Brookhaven Instruments Corporation 750 Blue Point Road Holtsville, NY 11742-1832 USA
Introduction: The choice of a particle size analyzer has never been more difficult. There are several techniques from which to choose and variations within each technique. Sales literature claims of specification and performance have become highly inflated, confusing the first-time buyer; the result has been to hinder and not help the decision making process. Many particle sizing ...
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Soon after the financial meltdown began late last fall, J. Leslie Glick, Ph.D. (see sidebar on profile of Dr. Glick), who is a staunch supporter of capitalization and free enterprise, proposed the government provide stimulus monies to VC firms to ensure the continued growth and financial stability of the U.S. life sciences industry. In exchange for taxpayer investment in these firms, the federal government would become a limited partner (like other private investors in a firm's funds) and share ...
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Most of today's pharmaceutical film coatings are aqueous polymer dispersions, while a small portion use organic solvents, which have several disadvantages, including toxicity, flammability, and cost. Although aqueous film coatings eliminate the disadvantages of solvents, they use a lot of energy to heat-cure the coatings, usually require long processing times, are potentially at risk for microbial contamination, and may be unsuitable for moisture sensitive products.
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Introduction The under treatment of post operative pain has been recognized to delay patient recovery and discharge from hospital. Despite recognition of the importance of effec- tive pain control, up to 70% of patients still complain of moderate to severe pain post operatively1.The most commonly used model to test the effect of new analgesic drugs in post operative pain is the Brennan model in rats. Although, this model can provide good answers to systemic drugs it is less suitable for testing ...
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A Paradigm Shift in the Pharmaceutical Sales Model
By: Richard W. Johnston Vice President and Founder, AdvantageMS
Property of Advantage Management Solutions, Inc Confidential
A Paradigm Shift in the Pharmaceutical Sales Model
Over the last twenty years the pharmaceutical industry has experienced extraordinary sales growth as a result of new product introductions, market expansions and the increase of aggressive sales strategies and tactics. During this same time, the ratio of physicians to ...
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Purpose: A generic approach is presented that provides concrete, statistical
evidence for acceptable method performance prior to initiating a bioanalytical
method validation.
Methods: A large number of replicate spiked matrix samples are analyzed in a
single batch before a method validation is started. Careful selection of the
contents of this batch enables one to evaluate factors such as the intra-assay
precision, linearity, working range, maximum batch size, carryover and
calibration ...
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Contents Introduction ........................................ ........................................ ........................................ ...........1 Why Is $/MB a Wrong Metric? ........................................ ........................................ ..........................1 What are TCO and ROI? ........................................ ........................................ ..................................1 Why Should Hitachi Data Systems Customers Care about Storage ...
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A sensitive radioimmunoassay (RIA) method was validated for the determination of octreotide in male rat plasma using reagents provided in the kits by Peninsula Laboratories, Inc. (Belmont, CA). The components provided in the RIA kit were used to validate octreotide in male rat plasma over a concentration range of 80-1280 pg/mL.
Octreotide mimics the action of somatostatin, a naturally occurring hormone found in the brain and gastrointestinal tract. Somatostatin is one of several substances ...
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A Randomised, Single-Dose, Two-Period, Cross-Over Phase I Pharmacokinetic Study to Compare TDS®-Diazepam with Rectal Diazepam in Healthy Adult Subjects.
F Al-Otaibi1, A Johnston1, AT Tucker1,2, T Lee3, R Langford1,4, K Kirby6, S Ratcliffe4, CAS Alam5
1Clinical Pharmacology, 5Experimental Pathology, WHRI, QMUL; 2Clinical Vascular & Microvascular Unit, and 4Anaesthetics Department, Barts and The London NHS Trust, 3Analytical Unit, St George's University of London, 6The Langford ...
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Pre-filled syringes are quickly becoming a viable alternative to vials. Review the benefits they offer, including reduced overfill requirements, decreased waste and enhanced product differentiation.
Prefilled syringes are a fast- growing alternative to vials in the parenteral product market due to the many advantages they offer relative to vials. These include reduced overfill requirements, ease of use, more accurate dosing, decreased waste, and enhanced product differentiation. Conventional ...
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Zeta potential is a useful property
to know for colloids, nanoparticles, and proteins.
It is a substitute for the otherwise hard to
measure surface charge. The zeta potential is not
equal to the surface potential but rather it is the
electrostatic potential difference between a rotationally
averaged point at the shear, i.e., the slip
plane, and an average point out in the liquid.
Particles with the same sign zeta potential repel
each other and thus maintain dispersion ...
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Human plasma samples spiked with apomorphine and internal standard were extracted using a liquid/liquid extraction technique. Quantitation was performed on a PE Sciex API 3000 LC-MS/MS system with Turbo Ion Spray operating in positive ion Multiple Reaction Monitoring (MRM) mode. Standard curves were produced by linear regression using the peak area ratios of analyte to internal standard and a 1/x weighting.
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Two possible approaches are considered as a foundation for the paper‐and‐pencil screening tool: a logistic regression or a classification tree. Both approaches have advantages and disadvantages and, therefore, both are considered. The traditional approach – logistic regression – is well grounded in statistical theory, but the resulting probability equation does not easily translate to a simple check‐box model. A classification tree is amenable to either a check‐box or flowchart format, (but ...
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Background: The University of Virginia School of Medicine dis- continued animal vivisection in February 2004 for teaching lifesav- ing procedures to third-year medical students. Consequently, a 1-day course using simulation technology was developed to meet objec- tives previously covered in the animal laboratory. The authors sought to evaluate the course and hypothesized that the students' condence in lifesaving procedures as well as their acceptance of simulation technology as a teaching tool ...
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A sensitive, simultaneous and rugged LC-MS/MS method was developed and validated for the quantitation of cortisol and 6ß-hydroxycortisol in human urine. Changes in ratio of 6ß-hydroxycortisol/cortisol in response to a drug is an indi- cation of induction/inhibition of CYP3A enzymes.
Calibration curves and QC samples were prepared in a surrogate matrix. Endogenous levels, recovery of spiked samples and stability data were determined using human urine.
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The purpose of this study was to validate a sensitive and specific LC-MS/MS assay to determine the human urine levels of dextromethorphan and three metabolites (dextrorphan, 3-methoxymorphinan and 3-hydroxymorphinan) in support of metabolite screening studies.
Urine samples were spiked with the analytes and internal standard, hydrolyzed with ß-glucuronidase at 37ºC overnight, and subjected to liquid/liquid extraction. Separation was performed by HPLC utilizing a Zorbax Rx C-8 (2.1 x 150 mm). ...
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Outsourcing is one of the commonly used approaches by pharmaceutical companies. Increasingly, pharma and biotech firms are searching for new drivers of revenue and profit growth. There are a number of trends and forces within the pharmaceutical industry that are causing companies to rethink their approaches to growth and cost management.
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A Q&A with AstraZeneca CEO David Brennan where he reveals the future of his company, what he's learned on his recent travels, and how the pharma industry must change.
What trends are you seeing in the pharma marketplace as a result of the economic crisis? How is this impacting the debate on health reform in the United States? The pharmaceutical industry is not as exposed to the boom and bust cycles that affect other sectors. So, while we are not immune to economic downturn, we are likely to ...
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Presenting data on the accuracy and reproducibility of the small-volume, completely automated BioSpec-nano spectrophotometer for dsDNA quantitation.
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ACT! helps you organize all the details of your customer relationships in one place for a complete view of the people you do business with. This centralized contact data helps individuals or teams find contact information and coordinate schedules quickly and easily. In addition, users can integrate ACT! with certain Microsoft Office applications, such as Microsoft Word, Microsoft Excel®, Microsoft Outlook® and Internet Explorer®, to further leverage their contact data.
As Office is widely ...
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In CRM at the Speed of Light: Essential Customer Strategies for the 21st Century, Paul Greenberg says usability “is perhaps the most important factor related to systems that you are going to install at your company. Usability needs to be considered a major design factor and is certainly a component of total cost of ownership.”1 At Sage, we certainly agree. Usability is a cornerstone in creating the user experience of our products—and productivity is the impact.
The Usability Professionals ...
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Architecture, Customization, and Integration
Table of Contents Introduction ........................................ ........................................ .................................... 3 ACT! Architecture Overview................................ ........................................ .................... 3 Database Layer................................... ........................................ .......................... 4 The Business Logic ...
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The ACT! application provides its own Report Writer that offers a number of stock Reports, Envelopes and Labels which allow users to produce a variety of reports and correspondence. These items are based upon templates which can be further modified or copied to create a customized and specific solution as needed. Template customization1 is performed by the user right from within the application using the ACT! Report Designer.
In addition to Report Templates, the ACT! architecture provides four ...
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The electrical properties of contractile proteins contribute to muscle structure and perhaps function but have not been characterized adequately. Electrophoretic mobility, íe, is sensitive to the net electric charge and hydrodynamic size of a molecule in solution. Zeta potential, ú, particle charge, Qe, and particle charge-to-mass ratio are proportional to íe. We measured íe for nucleotide complexes of skeletal muscle heavy meromyosin (HMM) and subfragment 1 (S1). The results indicate that íe ...
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Ion Database: Mass Spectrometry of Intact Microbes Ionization and Analysis by MALDI-TOF MS Martin A. Winkler, Ph.D. Available in an Amazon Kindle edition at Amazon.com Database Format, © 2009 by Martin Winkler Las Cruces NM 88005 2009
I. Introduction 2 II. Database: Ions sorted by m/z 3 III. Database: Ions sorted by Bacterial Species 12 IV. Database: Ions sorted by Reference 21 V. Matrices 30 VI. References 31
INTRODUCTION The following database of ions was compiled from peer-reviewed ...
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An Object-Oriented, Standards- Based Platform for Flexible Enterprise Planning Applications
An Oracle White Paper Updated September 2006
Demantra solutions consistently leverage technology standards, increasing the interoperability of existing applications and the exchange of data with external systems. This approach allows an organization to focus on functional needs and accelerate the deployment of business planning applications by automatically coordinating all enterprise technologies into ...
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In an earlier paper entitled "A Paradigm Shift in the Pharmaceutical Sales Model”, a case study was presented suggesting that a shift from a provider- based strategy to one that incorporates the group dynamic significantly increases ROI. In that case study we illustrated that, by developing a targeting strategy focusing on high-valued groups, the same market coverage could be achieved with 33% fewer FTEs1. When this analysis was further extended using a hybrid model targeting high decile ...
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53 Progress Avenue Springfield, MA 01104 Tel 413-736-5020 Fax 413-736-8257 info@sphinxadsorbents.com
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Incremental sensors are used in a wide range of industrial settings wherever displacement, angle, linear or rotational speed, or other time-based physical quantities are to be measured.
Resolution is critical in control, and other precision angular applications, such as machine tooling and differential rotational speed measurements. Enhancements of the signal resolution can also be achieved by using a second incremental signal track. The most common technique, of multiplying the two tracks, ...
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Prescription drug development continues to increase in importance. In 2006, U.S. biopharmaceutical companies invested $56.1 billion in research and development of which $44.9 billion was conducted in the U.S.1 In 2008 alone, the U.S. Food & Drug Administration approved 24 new drugs.2 Pharmaceutical, biotechnology, chemical and healthcare companies are involved in the effort to identify new compounds that will ultimately become the drugs of tomorrow. To find appropriate methods for handling and ...
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National Provider Database Streamlining MDM Processing
The AdvantageMS National Provider Database (NPD) provides clients a consolidated data set for MDs, DOs, NPs and PAs. Organizational and Government files as well as the AdvantageMS and the American Medical Association telecenter data research source files are all compiled processed and delivered through the AdvantageMS Best Of Breed (BOB) record. The BOB algorithm takes into account the historical accuracy of all source files on a weighted ...
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AdvantageMS Selected for Best Address Pilot
Fort Washington, PA: AdvantageMS is pleased to announce that it's Best of Breed (BOB) address for Providers has been selected as the most accurate as compared to competitive offerings in a pilot conducted by a top 10 Pharmaceutical Manufacturer.
Top data quality issues encountered by our clients:
· Provider addresses: 37% inaccurate · Deceased Status: 7% of clients “active” are in fact deceased · Retired Status: 4% of client's active are in ...
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In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions.
The Commonwealth of Puerto Rico provides unparalleled value as a location for high quality cost effective ...
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Microalbuminuria is an important and well established biomarker in patients with type 2 diabetes, due to its association with progressive renal disease. However, recent studies suggest that microalbuminuria may be considered as an independent marker for cardiovascular disease in patients with hypertension as well as diabetes(1,2,3) the prevalence increasing with age and duration of hypertension.
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Alternate Cleaning Procedures: Ashing Glassware; Ashing glassware reduces all organic compounds to a mineral & carbon ash. To ash, place suitable ware in an oven set at 842°F (450°C) for at least 3 hours. Allow ware to cool, rinse & clean as per stated in the Bellco's General Cleaning Procedures or follow your cleaning protocols. Chromic Acid Wash: Follow all normal safety precautions when using concentrated acid solutions. Acids can severely burn the skin. Dispose all acids properly. A chromic ...
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An Alternative Approach to Bioequivalence Studies for Semi- Solid Dosage Form Products
Bioequivalence Study Requirements for Semisolid Dosage Form Products
The guidance on Scale-Up and Post Approval Changes (SUPAC)1 for drug products is an informal document representing the best current scientific judgments of the FDA. Its intended purpose is to lower the regulatory burden on the industry while continuing to assure the safety and effectiveness of drug products. SUPAC guidance is developed ...
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H2NOMe 1 Methyl 2-Methoxy-4-Amino-5-Chloro-Benzoate- [Carbonyl-14C] (MMACB-14C)1 is an important intermediate in the synthesis of several Carbon-14 labeled API's. Compound 1 was needed as an intermediate for a synthesis that required seven additional steps that resulted in an overall yield of 36%. A better route was requred to make the synthesis more efficient.
Previous synthesis1,2 of (MMACB-14C) has been performed using 4-amino-2-hydroxy-[carbonyl-14C] benzoic acid as the starting ...
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The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced by the FDA, which focuses on an integrated approach of good science and good engineering practices ...
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GraphLogic Inc. GraphLogic Inc. sgold@graphlogic.com dbaker@graphlogic.com
Abstract An Executable Graph Component Database (EGCD) for defining and executing computer programs is described. An EGCD incor- porates every aspect of a computing program, including process flow and logic, user interface definition, database schemas and persistent data. The major elements of an EGCD system are de- scribed, including the Graph Component Database (GCD), whose core components are nodes, edges and ...
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Alprazolam and midazolam are known CYP3A4 inhibitors and are used in the investigation of potential drug-drug interactions in clinical studies.1 A sensitive and specific HPLC-MS/MS assay method for the simultaneous determination of alprazolam, midazolam and their α-hydroxy metabolites in human plasma was therefore developed and validated according to the current industry guidelines.2 The calibration range for the method is 0.100 to 10.0 ng/mL for alprazolam and midazolam; and 0.200 to 10.0 ...
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Budesonide is an anti-inflammatory, synthetic corticosteroid used for the treatment of asthma by oral inhalation.The objective was to validate a sensitive and specific HPLC-MS/ MS assay to determine budesonide in human plasma for support of Sheffield Pharmaceutical clinical trials. An automated 96-well HPLC-MS/MS assay method for the determination of budesonide in human plasma was therefore developed and validated according to the current industry guidelines.1 The calibration range for the ...
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Erythromycin is a known CYP3A4 inhibitor and is used in the investigation of potential drug-drug interactions in clinical studies.1 A specific HPLC-MS/MS assay method for the determination of erythromycin in human plasma was developed and validated according to the current industry guidelines.
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Erythromycin is a known CYP3A4 inhibitor and is used in the investigation of potential drug-drug interactions in clinical studies.1 A specific HPLC-MS/MS assay method for the determination of erythromycin in human plasma was developed and validated according to the current industry guidelines.2
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Oxycodone (a semi-synthetic derivative of morphine) is a narcotic analgesic or a narcotic painkiller used to relieve moderate to severe pain. Quantitative analysis is required for the determination of oxycodone and two of its metabolites, noroxycodone and oxymorphone in the clinical studies. A sensitive and specific HPLC-MS/MS assay method for the determination of oxycodone and two of its metabolites, noroxycodone and oxymorphone, in human plasma was therefore developed and validated according ...
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Noroxycodone Abstract An HPLC-MS/MS method was developed and validated for oxycodone and two of its active metabolites, oxymorphone and noroxycodone, in plasma at ABC-Europe in the range of 0.200 - 100 ng/mL.The method was subsequently validated at ABC-US.
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Picolinic acid is an endogenous biologically active molecule which serves as the body's natural chelator of certain transition metals, such as zinc. Picolinic acid is a terminal metabolite generated from the catabolism of tryptophan.The circulating levels of picolinic acid are proposed to change in certain pathological conditions and during therapy.
A sensitive and specific HPLC-MS/MS method was developed and validated for the quantitation of pico- linic acid in the linear range of 10-1000 ...
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The objective was to validate a sensitive and specific HPLC-MS/MS assay to determine the concentration of PL-2299 in human, rat and beagle plasma for support of Palatin Technologies, Inc. preclinical and clinical studies.
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An HPLC-MS/MS method was developed and validated for rifabutin in plasma with a linear range of 5.00 to 800 ng/mL. Rifabutin is a semisynthetic antibacterial agent for use against diseases such as Mycobacterium-avium complex in HIV-positive patients. The HPLC-MS/MS method developed was validated for the determination of rifabutin in human plasma.
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A sensitive and rugged HPLC-UV method was developed and validated for the quantitation of 2,3-dihydroxy- benzoic acid (DHBA) in the linear range of 10-1000 μg/mL in rat, dog, and human plasma. DHBA is a metabolite of 2,3-diacetoxybenzoic acid (DABA).
2,3-dihydroxybenzoic acid (2,3-DHBA) is a product of salicylate metabolism produced through the action of the hydroxyl radical. This compound can be used as a marker to assess hydroxyl radical formation both in vitro and in vivo. In addition, ...
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Nolatrexed dihydrochloride, a thymidylate synthase inhibitor, is a novel oncology compound that is being developed to treat several different cancers, with an initial emphasis in hepatocellular carcinoma (liver cancer). Nolatrexed dihydrochloride is currently in a Phase III trial for the treatment of unresectable hepatocellular carcinoma.
A sensitive and specific HPLC-UV method was developed and validated for the quantitation of nolatrexed dihydrochloride in the linear range of 0.250- 20.0 ...
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Presentation delivered at ALA Lab Automation 2010
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A sensitive and specific LC-MS/MS method was developed for the quantitation of 7-hydroxycoumarin, resorufin, hydroxytolbutamide, 4' hydroxymephenytoin, 6ß- hydroxytestosterone, dextrorphan, 6-hydroxychlorzoxazone and 12-hydroxylauric acid metabolites generated by cytochrome P450 enzymes using standard probe substrates.
The analysis was conducted using a calibration curve prepared by fortifying metabolites in the incubation buffer only.The method performance was validated by analyzing quality ...
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Previously, four HPLC-MS/MS methods using two columns with multiple injections were used to monitor nine CYP P450 Isozyme activities (Method I). Using this method was not efficient or cost effective. Therefore one optimized HPLC-MS/MS method (two ionization modes) was developed to monitor the activities of all nine Isozymes (Method II).
Frozen pooled (male and female) human liver microsomes were used during the course of the project. Thawed microsomes (~20 mg protein/mL) were diluted 10 fold ...
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An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals Robert H. Ku, Ph.D., CIH, Principal Toxicologist [Published in Chemical Health & Safety, January/February 2000]
Setting appropriate occupational exposure limits is an integral component in assuring the health and safety of workers
Introduction Occupational exposure limits (OELs) 1 for the protection of workers have been around at least since 1939 when the National (later changed to American) Conference of ...
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Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success.
A biopharmaceutical formulation consists of active pharmaceutical ingredient and other ingredients that help maintain the drug product's chemical, biochemical, and physical ...
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Presented here are outsourcing strategies, advantages/challenges and best practices of outsourcing, compliance expectations of a contract laboratory, and development/validation of analytical methods.
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Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor throughout the production process.
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In the lucrative business environment of horse breeding there are time and cost pressures to improve the tools currently used to predict ovulation and streamline the breeding process. The standard methods of determining optimum breeding time in horses include daily transrectal ultrasonography to follow and measure a dominant follicle during estrous as well as progesterone assays as an indicator of cycle status. This strategy alone often results in failed breeding attempts and excessive visits ...
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It is an increasingly common practice to enhance the efficacy of drugs or therapeutic agents with the conjugation to PEG. The attachment of PEG to a drug or therapeutic protein increases the in vivo half life of the agent by altering the surface of the molecule. The result is improved drug solubility, increased stability, and decreased immunogenicity, resulting in extended circulating life. With such innovation comes the need for new tools to validate, track and improve upon the process. Maine ...
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What is an antibody? An antibody is an immunoglobulin protein, secreted by B lymphocytes, that is present in serum or body fluid and combines specifically with an antigen. Antigens are classically defined as any foreign substance that elicits an immune response. An antigen that produces an adaptive immune response after injection into an animal is an immunogen. Immunogens can be designed so that antibodies are generated against specific proteins. Because antibodies can be made against specific ...
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Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H- dibenzo[de,g]quinoline-10,11-diol) is a dopamine receptor agonist under development for the treatment of erectile dysfunction.The purpose of this study was to characterize the in vitro metabolism of apomorphine by hepatocytes from human, rat, and dog. Solutions of 14C-labeled and nonradiolabeled apomorphine were incubated with primary hepatocytes at 1, 2, and 4 hours. Samples of the incubation media were analyzed by HPLC with radiodetection. ...
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The Development of Solubility and Metastability Design Spaces UCD Crystallization Research Group, Schoolof Chemical and Bioprocess Engineering, University College Dublin, Ireland and the Solid State Pharamaceutical Cluster (SSPC) Ireland Email: mark.barrett@ucd.ie
Background: The HEL polyblock system was used, in conjunction with the polythermal method, to
create solubility and metastability design space information for two API compounds. By creating a solubility design space a fundamental ...
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In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is a need to conduct qualitative and/or quantitative healthbased risk assessments for both occupational and product (patient) safety purposes. When performed from an occupational standpoint, qualitative health-based risk assessments involve the categorization (“banding”) of the API based on toxicity and potency, which provides a measure of relative hazard. Each occupational health categorization is then ...
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The word biocompatibility refers to the interaction between a medical device and the tissues and physiological systems of the patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models, in vivo tests. The biocompatibility of a device depends on several factors, including:
the chemical and physical nature of its component ...
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Concern regarding extractables and leachables has been increasing over the past few years, as evidenced by regulatory guidance documents [1-3]. One means of qualifying a component as being suitable for use in a drug product is to determine the extraction profile of that component in multiple solvents with polarities similar to and bracketing that of the product vehicle. Any observed extractables can then be identified and potential leachable concentrations assessed by a toxicologist to ...
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The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed paper records. The electronic records in the Veriteq system are controlled such that, once created, ...
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The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed paper records. The electronic records in the Veriteq system are controlled such that, once created, ...
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Drug innovators, collaborators, licensing partners and the myriad of third parties who handle active pharmaceutical ingredients (APIs) need to take notice when the APIs they are handling have the following properties – clinical doses less than 10 milligrams causing pharmacological or toxic effects in patients or if low doses (less than 1 mg/kg/day) in laboratory animals may potentially be “-genic” (i.e, they are mutagenic, teratogenic, carcinogenic or are reproductive or developmental ...
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Autoclaving the Spinner Flasks, they should be Autoclaved at 121 Degrees Celsius @ 15psi.
For at least 45 minutes or depending on your labs protocol. They can be Autoclaved in an Autoclave Bag or as they are making sure that the caps are not put on tight. Tighten them down and then back off about a half turn so that they are loose. This is important so as to protect the vessel and caps from any potential vacuum that will form during the cool down cycle causing the caps to crack and also to ...
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