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Bioequivalence and Bioavailability

    
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BioScience Laboratories, Inc.  A FDA / EPA registered, GLP and GCP, Microbiology, Virology, Toxicology analytical testing facility providing product safety / efficacy / custom testing, product development, product differentiation, and regulatory...
 
Bioavailability/Bioequivalence Studies bioavailability/bioequivalence studies for generic pharmaceuticals
 
Testing Services Comprehensive microbiology, virology, toxicology Testing Services
BASi - Bioanalytical Systems, Inc.  bioanalytical sample analysis automated in-vivo blood sampling toxicology pharmaceutical analysis electrochemistry EC liquid chromatography LC Vetronics
 
In Vitro Bioequivalence Analysis BASi has extensive experience with bioavailability (BA) and bioequivalence (BE) studies. All BA and BE studies are performed in accordance with 21 CFR...
Aptalis Pharmaceutical Technologies  Aptalis Pharmaceutical Technologies specializes in product development that leverages our proprietary pharmaceutical technologies in taste masking, customized drug release and bioavailability enhancement.
 
Bioavalibility Enhancement Enhancing the bioavailability of poorly soluble drugs Is there a promising drug in your pipeline with low bioavailability or a drug in your portfolio that...
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
Bio SRL  Biosrl is a vibrant CRO, established in the year 2003, located at Mira Road, spread over an area of 12,500 sq.ft. We provide a range of research services like Analytical, Bioequivalence & Bioavailability & Clinical trial...
Atlantic Life Sciences  Full GCP approved CRO of clinical services of: Bioavailability/Bioequivalence clinical trials. Early stage of clinical development: First-in-man and Phase I clinical studies.
 
Bioavailability / Bioequivalence studies Our expertise of phase 1 clinical trials is an asset for bioequivalence and comparative biosimilar studies.
Pharmaceutical Generics  Semler Research Center (SRC) is part of US based Arnold A Semler Inc, in business since 1946. SRC, founded in 2006, is a privately owned pharmaceutical services company with its business offices in Los Angeles, CA and...
Warnex Inc.  Warnex is a life sciences company devoted to protecting public health by providing laboratory services to the pharmaceutical and healthcare sectors. Warnex Analytical Services provides pharmaceutical and biotechnology...
 
Bioanalytical Services Warnex Bioanalytical Services offers a range of services to the pharmaceutical and biotechnology industries, specializing in bioavailability and...
Algorithme Pharma, Inc.  Algorithme Pharma is a research organisation specializing in early stage clinical trials and bioanalysis. Over the years we have established considerable international experience conducting bioequivalence and Phase I/IIa...
ALTASCIENCES COMPANY INC.  In order to strategically support enhanced organic growth and business diversification, we are proud to introduce our new global identity: ALTASCIENCES COMPANY INC., based in Montreal, Quebec (Canada). ALTASCIENCES,...
BioCor  The mission of BioCoR is to advance the science, technology and practice of biospecimen preservation by developing specific biopreservation protocols, improve preservation and storage technologies, establish standards and...
 
BioCoR Resources BioCoR is not a biorepository but a national core resource on biopreservation. BioCoR provides three basic functions: (1) a Service Resource for those who...
Semler Research Center  Semler Research Center (SRC) is part of US based Arnold A Semler Inc, in business since 1946. SRC, founded in 2006, is a privately owned pharmaceutical services company with its business offices in Los Angeles, CA and...
 
Services Our expertise in formulation development extends to the development of all conventional dosage forms. Our strategic alliances broaden the scope to consider...
Celerion  clinical research, clinical pharmacology sciences, bioanalysis, drug development, laboratory, CRO, PK, drug, metabolism, first in human, FIH, proof of concept, adaptive study designs, consulting, bioequivalence, phase I,...
 
Clinical Pharmacology Sciences Clinical Pharmacology Sciences at Celerion bridges the gap between medical practice and laboratory science by assessing the safety of drug products to...
 
Global Bioanalytical Services With nearly 40 years of experience working with large and small molecules, Celerion uses the most advanced technologies and strategies to meet clients’...
 
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Bioequivalence and Bioavailability - Product Reviews

Plume geometry is one attribute tested in bioavailability and bioequivalence studies of nasal inhalers: vaccines are being developed that can be delivered by nasal inhalers

Bioavailability (BA) and bioequivalence (BE) studies of nasal inhalers measure plume geometry to document compliance with FDA regulations. Delivery of the drug to the mucus membranes on the insides of the nostrils is essential for proper absorption. A jet-like spray will deliver the medicine to the back of the nose where it will simply trickle down the back of the throat. Too wide of a spray will result in some of the drug being sprayed on the edges of the nostril, an area that does not have the absorption capability of the mucus membranes. 

Research into the viability of using nasal inhalers as a delivery system for vaccines is gaining popularity because of the ability of this system to solve some unique problems. Vaccine formulations typically require cold-chain storage and transport. This protocol is impractical when dealing with populations in geographic regions that are either remote or lack a reliable power source, countries without an established healthcare infrastructure and when responding to crisis situations. To date, the only inhalable vaccine available is the flu vaccine; however, a dry powder inhalable measles vaccine is scheduled to undergo clinical trials in 2010 in India. Dr. Robert Sievers, the leader of the team that developed this vaccine, said, “Not only might (inhalable vaccines) reduce the risk of infection from HIV, hepatitis, and other serious diseases due to unsterilized needles, they may prove more effective against disease.” Bioavailability and bioequivalence studies will ensure the identity, strength, quality, purity and potency of this and all future inhalable vaccines.

Best-in-Class Bioavailability and Bioequivalence Features:

  • Performs in vitro BA studies on samples from three or more batches: a clinical batch to link in vitro performance with in vivo data, a primary stability batch and a production-scale batch.
  • Uses standard of less than 5% difference between drug concentration in the test and reference product formulations.
  • Validates the accuracy and precision of all in vitro tests before beginning the study.

 Top Considerations Before Selecting Bioavailability and Bioequivalence Providers:

Compliance with government regulations is very important. These regulations differ from country to country and are always evolving. Make sure that your provider understands the importance of compliance and stays current with the rules and procedures.

Key Producers:

1. Rules-Based Medicine, Inc. (RBM), founded in 1998, uses Multi-Analyte Profiling (MAP) technology to help companies make their drug development programs more efficient and effective. RBM is the world's leading laboratory testing biomarkers, which are used to determine the biochemical reason that some patients respond better to a therapy. Corporate headquarters and CLIA-certified biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and its wholly owned subsidiary EDI GmbH is in Reutlingen, Germany. Through EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems which serve as a platform for ex vivo drug safety and efficacy studies. By combining EDI’s cell culture systems with its HumanMAP® biomarker testing services, RBM is able to offer customers a preview of the physiological and biochemical impact of a new drug before the human trial stage begins.

2. The Jackson Laboratory fulfills its mission statement of “discover(ing) the genetic basis for preventing, treating and curing human disease, and…enable(ing) research and education for the global biomedical community" by offering academic programs for teachers, and high school through predoctoral students, as well as offering student internships and hosting events on campuses. In addition to conducting genetic research, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Its more than 1,400 employees are work in offices  in Bar Harbor, Maine and Sacramento, California.

3. Diteba Research Laboratories Inc., a contract research organization (CRO), provides a wide range of analytical and bioanalytical research and testing services, including raw material, active ingredient and finished product testing and commercial stability studies to the pharmaceutical, biopharmaceutical and nutraceutical industries. Its academic network, along with a newly built world-class pharmaceutical laboratory and a Scientific Data Management System, enable delivery of a range of R&D services. Diteba offers customers a comprehensive information infrastructure in order to guarantee Quality Assurance and Compliance with electronic signature and electronic audit trail regulations, and employs best-in-the-industry practices and methods to manage all areas of the drug development process. Diteba, founded in 2003, is a private corporation located in Toronto, Ontario.

4. GVK Biosciences Private Limited (GVK BIO) is an Indian CRO which offers process research and development, including process development, analytical development, quality, and IP management; clinical, bioavailability, and bioequivalence studies; clinical trials  and data management to global Pharma and Biotech companies. They report that they have nearly 100,000 square feet of laboratory space. The company, incorporated in 2000, is based in Hyderabad, India and has a clinical pharmacology unit in Ahmadabad. GVK Biosciences Private Limited operates as a subsidiary of GVK Power and Infrastructure Ltd.

Bioavailability and Bioequivalence
Definition: A study used to compare a test product to a reference product by determining its bioavailability and bioequivalence. Bioavailability (BA) is the relative degree of absorption and the rate that the active ingredient in a drug or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of action. Bioequivalence (BE) is achieved when there is no statistical difference between the rate and extent of absorption of the active ingredient from those of a reference product which has been administered at the same molar dose under the same conditions as the active ingredient. BE involves the comparison of the BA of one product with the BA of another product.

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Bioequivalence and Bioavailability Research Library

Maximizing Drug Delivery Technologies in Today's Pharmaceutical Environment
Aptalis Pharmaceutical Technologies
The science & business of drug development in specialty pharma, biotechnology, and drug delivery William E. Lucie Guy-Charles Weiser, PhD Mondoulet, Fanneau de la Outsourcing PhD Horie, MBA Formulation Viaskin®: Beyond Development: Epicutaneous Monoclonals for A Continuum on Immunotherapy Severe the Road to Drug for Treating Food Autoimmune Development Allergies Diseases INTERVIEW WITH APTALIS ...
 
Determination of an Acceptable Preservative for...
BASi - Bioanalytical Systems, Inc.
This method uses a 50:50 THF:water extraction solvent for the preparation of standards and samples. Preservative at a level of 0.1 weight percent in solution was added to stabilize the preparations. Analysis was accomplished by HPLC carried out on a Phenomenex Luna Phenyl Hexyl (150 x 4.6 mm) column at a flow rate of 1.0 mL/min. The separation was completed with a mobile phase of 35 mM ...
 
Inflammation Application Notes - Multiplexed Immunoassays for Quantitative Measurement of Biomarkers Involved in Immune Response
Myriad RBM, Inc.
Chronic inflammatory processes are associated with a remarkable range of human diseases including numerous cardiovascular, pulmonary, neurodegenerative, and autoimmune disorders. Advances in our understanding of inflammatory biomarkers and their role in disease offer tremendous clinical value. Myriad RBM’s multi-analyte profiling (MAP) technology provides comprehensive, quantitative and ...
 
LC-MS/MS Assay for Itraconazole and Hydroxy-Itraconazole in Human Plasma for Bioequivalence, Bio
Frontage Laboratories, Inc.
Read how a simple high throughput LC-MS/MS method has been developed and fully validated for simultaneous determination of itraconazole and hydroxyl itraconazole in human plasma. The method is specific, sensitive, and reproducible and has been successfully used in support of a clinical PK study and also can be used for supporting bioequivalence and bioavailability studies.
 
An Alternative Approach to Bioequivalency Studies Utilizing In Vitro Release Rate Studies
NDI ADRL Inc. dba Diteba
Find out how you can optimize your formula for in-process testing, control quality better and avoid lot-to-lot variability and be in full compliance with SUPAC and FDA guidelines for pre and post-change formulations, manufacturing site transfers, using skin penetration studies for BA/BE evaluations and interpreting the data generated for SUPAC submissions.
 

Bioequivalence and Bioavailability Video

Biorise Bioavailability Enhancement Technology Aptalis Pharmaceutical Technologies Improved oral bioavailability of poorly soluble compounds resulting in equivalent therapy at lower doses.
 
Diteba's Capabilities Presentation NDI ADRL Inc. dba Diteba Explore Diteba's Laboratory Testing capabilities and find out how we can help you turn your research into reality and expedite the process of bringing ...
 
Bioequivalence and Bioavailability BASi - Bioanalytical Systems, Inc. Information

Bioequivalence and Bioavailability News

Bioequivalence and Bioavailability Myriad RBM, Inc. Products
Bioequivalence and Bioavailability Union Standard Equipment Company
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