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What is the best way to measure rancidity in my sample? That is an often asked and simple question that, unfortunately, belies a simple answer. Many factors must be considered when selecting the most appropriate test or series of tests, and it is often difficult to predict which method will yield the most meaningful results.
What Causes Rancidity? Fats and oils play an important role in the flavor, aroma, texture, and nutritional quality of foods, pet foods, and feeds. Fats and oils may be ...
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The purpose of this paper is to discuss the application of Raman spectroscopy to the unique requirements of raw material testing. In order to do so we will answer the following questions:
1. What is and why perform identity testing? 2. What are the incentives to speed up testing? 3. Should we consider modifying the testing process? 4. How does the Thermo Scientific TruScan handheld Raman instrument perform ID testing? 5. How well does TruScan® work for common raw materials? 6. Can this be ...
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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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02 Contents 03 Product Lifecycle Management Maximizing profit and leveraging innovation 04 Maintaining a successful course 05 PLM options 06 Comfort for the user 06 Keeping an eye on developments 07 PLM basics: a head start and a long view
The cost of developing a new drug is continuously rising. Many other factors, such as stricter regulations and stronger global competition, are also creating major challenges. If a pharmaceutical company intends to increase its market share and return on ...
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02 Contents 03 Product Lifecycle Management Maximizing profit and leveraging innovation 04 Maintaining a successful course 05 PLM options 06 Comfort for the user 06 Keeping an eye on developments 07 PLM basics: a head start and a long view
The cost of developing a new drug is continuously rising. Many other factors, such as stricter regulations and stronger global competition, are also creating major challenges. If a pharmaceutical company intends to increase its market share and return on ...
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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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This white paper is intended for clinical operations managers who are either considering their electronic data capture (EDC) options for the first time or re-evaluating previous decisions. This paper looks at the primary approaches for acquiring, implementing and applying eClinical technologies with a particular focus on choosing the approach that best matches your organization’s goals and capabilities.
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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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DASGIP develops and manufactures technologically advanced Parallel Bioreactor Systems for the cultivation of microbial and mammalian cells at bench top scale. www.dasgip.com
o Parallel operation of 4, 8 or more vessels o Suitable for cell cultivation and microbial fermentation o Control hardware optimized for small scale process development o Hard- and software designed for efficient parallel operation o Results as good as and scalable to large scale runs
Groton Biosystems develops and ...
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Unifying materials, even though they are aimed at notably different buyers, yield significant impact on the perceptions both segments have about the size, scope and sophistication of BASi. The more modern and progressive visual presenta- tion has helped position them among the leaders in their markets.
“BASi had aggressive plans for growth that we believed simply could not be met without reevaluating our marketing. SCORR came in with a very reasoned approach, beginning with detailed research ...
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A Filamatic White Paper on the basics of liquid filling including filling techniques, metering systems, and nozzles
When beginning your liquid filling equipment search, it is important to consider the different aspects of your product (or application) and the demands of your project. There are four characteristics that will help in determining the type of filling machine you will need: the liquid’s nature or characteristics, fill volume(s), production rate(s), and container ...
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“Which product in a class should be on formulary?” “What are the economic benefits and risks to adding a product to Tier 2?” Managed care organizations (MCOs) have numerous decisions to make each day. Many of these impact their bottom line. Therefore, it is necessary for the information being used to make the decisions be correct and presented in a fashion that is easy to understand. Pharmacoeconomic models can achieve these goals. This article, the first in a series of three, discusses the ...
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Over the past several years people have become increasingly more conscious about the impact of their actions. This shift in how we view things has been largely awakened by economics and is also the case within the business world.
What is success and how do you define it? At times success can be difficult to recognize and how you define success has a major impact on the decisions you make.
In abundant times, times of success, we are less likely to consider or invest in changes or ...
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A global pharmaceutical manufacturer, facing cost challenges at one of its plants, had an operational excellence program up and running. But the program had not produced cost improvements of the magnitude or with the speed that the company sought. Looking for transforma- tion that would bring faster, sustainable improvement, the company then partnered with Tunnell.
The result: the company not only realized improvement on the scale and at the speed it needed, but also built a new culture of ...
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Boehringer Ingelheim gelheim SA, Colombia is a research-driven (BICO), who has been a group of companies presence in Colombia since dedicated to researching, de- 1962, made the decision to veloping, manufacturing and advance their technology marketing pharmaceuticals base in order to deliver that improve health and qual- higher levels of compliance in ity of life. The business con- supporting of Quality and sists largely of Human Product Control to its plant. pharmaceuticals (consisting One of ...
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We believe that the main reason for the apparent fall in productivity with increasing scale is the concomitant increase in organizational complexity. It is our premise that breaking Big Pharma into entities of more manageable scale will assist them in increasing R&D productivity. Horizontal disintegration (where end-to-end processes in the value chain are kept together, but the scopes of these activities are limited) and vertical disintegration (where end to end processes in the value chain are ...
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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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Ribavirin is an antiviral prodrug used for the treatment of Hepatitis C and respiratory syncytial virus (RSV) among other common viruses. A method for the analysis and quantification of ribavirin in rat plasma utilizing HPLC-MS/MS with updated HPLC column technology has been developed and validated according to the FDA guidance to the industry.
The assay displays good linearity with correlation coefficient >0.99 over a range of 10 – 5000 ng/mL using a 25 µL sample precipitated with 5mM ...
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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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Recent industry analyst reports predict that worldwide pharmaceutical industry revenues will grow at a compound annual growth rate (CAGR) of 8.58% through 2008. Worldwide biotechnology revenues are expected to grow at a compound annual growth rate of 25.96% through 2008 – this large growth rate is not surprising as many biotechnology and biopharmaceutical companies are just now moving products into the marketplace and generating significant revenue for the first time. Life Science Insights ...
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Shimadzu protein instruments open new avenues to speed biomarkers to the clinic
Discovery Verification Validation Application
Is a patient really sick? What medicine is necessary? In what dosage? Is the patient responding to it? Doctors customarily answer these questions based on a variety of symptoms. But many of the symptoms used today, because of their subjective description and uncertain relationship to the disease state, are misleading.
Scientists are rushing to find new `biomarkers' — ...
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Robert J Broeze is the President and Chief Executive Officer of Laureate Pharma. He has over 20 years of experience in the biopharmaceutical industry, with technical expertise spanning research, development, characterisation, validation and current Good Manufacturing Process (cGMP) manufacture of biopharmaceutical products, from pilot to phase III clinical and commercial scale with a strong emphasis on monoclonal antibody products for parenteral use. Prior to joining Laureate, Dr Broeze held ...
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In the clinical trial arena, pathology plays a critical role when
tissue specimens are an essential component for the diagnosis
and for assessing response to treatment, especially in oncology
studies. Studies involving tissue pathology require accurate and
standardised interpretations of specimens from similar areas
and are essential for the assessment of primary end points prior
to submission of the test product for approval to the FDA.
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Everyone has heard the saying that men are from Mars and women are from Venus. When it comes to implementing a global human re- source management system (HRMS), the same could be said for an organization’s in- formation technology and human resource departments.
IT and HR professionals should heed the advice of Men Are from Mars, Women Are from Venus author John Gray and learn how to communicate more effective- ly to ensure the needs of each are taken into consideration and that an ...
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Throughout the economic downturn of 2008 and 2009, which dramatically impacted IT service spending, the Business Intelligence (BI) market remained a bright spot. In fact, many vendors experienced double-digit or even triple-digit growth of BI-related services in 2009, while experiencing revenue declines through the remainder of their portfolios.
Challenging economic times have created the need for improved transparency across business functions, allowing vendors and end-users to identify areas ...
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This technical paper examines two solution methodologies and the various implementation strategies they provide. The first method is the traditional application development approach, which is based on an object-oriented design model and produces hard-coded applications. The second is a business process management (BPM) strategy that uses a process-oriented design model and delivers automated workflow solutions.
The purpose of this technical paper is to clarify the critical difference between ...
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This white paper explores many of the issues faced by both small and large life sciences companies when attempting to apply technology to the clinical trial process. It introduces the concept of business process management (BPM) and how this technology differs from traditional software applications. Additionally, it provides examples of BPM applications in the clinical trial process and explains how life sciences companies of any size can take advantage of the benefits provided by this ...
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Within the past several years there has been enormous innovation in the way workflow solutions are designed and built. In the past, using a process-oriented strategy was only successful under certain conditions as it was unable to adapt to situations that involved complex business rules. Many large corporations became frustrated by the failure of process improvement projects and resorted to using traditional application development techniques. In response to this limitation, the software ...
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This paper shows how two products, Microsoft® Office and Microsoft SharePoint®, contribute to the powerful architectural design of the Microsoft Business Productivity Infrastructure (BPI). The BPI stack approach suggests that only by thinking at a capability level (for example, “What do users want to do?‖), and then adding the right aspects of capability in each place (client, server, and services), can we create desktop applications that also deliver rich server and services capabilities to ...
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