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Bioequivalence Test

    
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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...
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...
 
Testing Services Comprehensive microbiology, virology, toxicology Testing Services
Pacific BioLabs (PBL)  Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the biological sciences,...
 
PHARMACOKINETICS AND RADIOLABELED ADME Pharmacokinetic studies are used to gather information on how a drug compound moves through and is processed by the body. This includes the absorption,...
Biological Test Center  The Biological Test Center has been serving the pharmaceutical and medical device industries with contract laboratory testing since 1980. Their 32,200 square foot, AAALAC-accredited, state-of-the-art facility is ...
 
PHARMACOKINETICS * Non-compartmental pharmacokinetics * Multi-dose Studies * Intermittent or continuous intravenous infusion * Bioequivalence 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...
Gateway Analytical  Gateway Analytical is a contract analytical laboratory and consulting company offering standard and novel analytical testing techniques to the pharmaceutical, materials science and forensics industries. More than just...
 
Analytical Testing Services A blend of innovative and standard techniques, our analytical testing offerings can reveal more information about a sample by utilizing novel techniques...
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’...
 
Apotex Inc.  Apotex currently produces more than 260 generic pharmaceuticals in approximately 4000 dosages. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to...
 
Apotex Bioequivalence Apotex Inc. has formulated their pharmaceuticals to contain the exact same chemical and to produce the same beneficial effects as the original brand name...
Elite Research Institute  Elite Research Institute is dedicated to providing the highest quality of Phase I - IV Clinical Trials services to the pharmaceutical industry. The Company is located in Miami, FL. The center has capacity of 100 beds...
PharmaNet Development Group, Inc  PharmaNet, a global, drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug, and medical device industries. PharmaNet offers clinical-development...
 
Biostatistics PharmaNet Consulting employs experienced biostatistics professionals who will focus on your research requirements and design an efficient and statistically...
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...
Columbia Analytical Services, Inc  A registered contract testing laboratory that provides cGMP-compliant testing to raw material suppliers, CMOs, and product developers/sponsors.
Ethix Pharma  At the preclinical stage of drug development, you must extensively test your product in the laboratory to ensure it will be safe for human administration. We understand that selecting a research and development partner to...
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Bioequivalence Test - Product Reviews

Computer program facilitates comparison of drug liberation profiles: faster bioequivalence testing now possible

The rate of drug liberation is only one of the many parameters measured during bioequivalence testing. Drug liberation or dissolution from solids is caused by a series of both simultaneous and successive processes including wetting, capillary penetration, swelling, disintegration and diffusion. The shape of the drug liberation-time curve for each dosage level of a particular drug, which is packaged in a particular medium, is unique. The mathematical equations for describing these curves are very complex.

A freely available computer program called DDSolver simplifies the mathematical calculations used to compare the drug liberation profiles of drugs undergoing bioequivalence testing according to Yong Zhang, et al. in AAPS Journal.  These researchers report that DDSolver can perform "most existing techniques for comparing drug release data" and that "Sample runs of the program demonstrated that the results were satisfactory."


Best-in-Class Bioequivalence Test Providers:

  • Ensure that the route of administration and intended use simulate actual conditions
  • Test for strength, quality and performance characteristics
  • Make sure drugs are comparable in dosage form


Top Considerations Before Selecting Bioequivalence Test Provider:

Data from bioequivalence studies may not be enough to gain regulatory approval. In the past, the U.S. Food and Drug Administration (FDA) has held up marketing of bioequivalent drugs until further analyses were performed like analytical method validation and in vitro-in vivo correlation studies. Your bioequivalence test provider should be able to give some guidance on the possibility of whether that may happen with your product.


Key Producers:

1. Rules-Based Medicine, Inc. (RBM) is the world's leading biomarker testing laboratory. RBM’s CustomMAP service can help researchers engaged in bioequivalence testing. This service involves the use of a larger more comprehensive MAP to cast a wide net in the search for novel biomarker patterns and then a smaller more focused MAP of just the biomarker assays of interest. Founded in 1998, RBM has corporate headquarters and CLIA-certified biomarker testing laboratory in Austin, TX; multiplex assay development and manufacturing in Lake Placid, NY and a wholly owned subsidiary EDI GmbH 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.

2. Cetero Research has expertise in the following types of studies: Bioavailability; Absolute Bioavailability; Bioequivalence; First-in-Human; Single and multiple ascending dose in healthy participants or patients; Proof-of-Concept; Interaction; and Drug-drug, drug-food, and alcohol interaction. Cetero has more than 20 years experience in bioanalytical research, which includes providing a quantitative measure of the active drug and its metabolites for bioequivalence studies. This company reports that “Our 50 instruments offer substantial capacity to analyze your samples…in a high-throughput environment to meet the most demanding schedules.” Cetero Research has two state-of-the-art facilities in Houston, TX and Toronto, Canada. This company was formed in 2006 and 2007 by the merger of five research companies that had all been in business since the 1980s.

3. The Jackson Laboratory supports bioequivalence testing by providing scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Services include testing numerous medicinal entities, including small molecules, antibodies, siRNAs and ES cell-derived therapies, as well as customizable compound evaluation, phenotyping and pathology services. It 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. A third laboratory in Florida will be added to its two existing facilities in Maine and California.

4. Atlantic Life Sciences Inc. offers Bioequivalence, Bioavailability, Nutraceuticals and Biosimilars clinical trial services for Phase 0 and Phase 1. Clients have the company’s undivided attention because it only conducts one study at a time. It takes 2 to 3 weeks for ALS to put a bioequivalence study in place and 3 to 4 weeks after collection of the last sample for the final report to be sent to the customer. ALS reports that "We gained the reputation of accomplishing complex studies on time and get them done right from the first time. Our studies pass the regulatory review and inspections successfully."


Bioequivalence Test
Definition: Test which is performed to see if bioequivalence (BE) is achieved. BE occurs 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 bioavailability (BA) of one product with the BA of another product.


 

More

Bioequivalence Test Research Library

Rat KidneyMAP
Myriad RBM, Inc.
A 12-Biomarker Multi-Analyte Profile (MAP) for Detecting Kidney Toxicity in Rat Preclinical Drug Studies. Sherry Sours-Brothers, Ph.D. and Dominic Eisinger, Ph.D. Introduction Rat KidneyMAP® and Biomarker Qualification by the Predictive Safety Testing Consortium Drug induced toxicity is responsible for killing 30% of promising compounds from early preclinical studies and can negatively impact ...
 
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.
 
In Vitro Testing eBook
NDI ADRL Inc. dba Diteba
This eBook is based on articles from Diteba's Blog and excerpts from the whitepaper "An Alternative Approach to Bioequivalence Studies for Semi- Solid Dosage Form Products". You will read insights from Diteba's Chief Scientific Officer and Executive Vice President of Science, Dr. Theo Kapanadze, D.Sc., Ph.D. Dr. Kapanadze has extensive knowledge and experience in this realm of study. He has ...
 
In Vitro Testing for Predicting Nasal Drug Absorption and Factors Influencing Nasal Membrane Permeability
NDI ADRL Inc. dba Diteba
In Vitro Testing Methodologies for Predicting Nasal Drug Absorption and Investigating Factors Influencing Nasal Membrane Permeability and Absorption Drugs have been administered nasally for therapeutic and recreational purposes since ancient times. In general, among the primary targets for intranasal administration are pharmacologically active compounds with poor stability in gastrointestinal ...
 
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 Test Video

Pacific BioLabs - A Bioscience Contract Research Organization Pacific BioLabs (PBL) Pacific BioLabs offers GLP/cGMP testing services to the biopharmaceutical, medical device, and combination product industries. PBL services include ...
 
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 Test BioScience Laboratories, Inc. Products

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