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Bioanalytical Services
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Custom Synthesis of Standards
Quality custom-made standards are important to any research project. Covance Custom Synthesis of Standards services can support any project with our in-house laboratories. Our experienced scientists, using innovative chemistries, can prepare any sponsor-defined compound. We also have a collection of in-house internal and reference standards, ready for immediate use.
Covance's small scale custom synthesis capabilities include:
- Small molecule drugs, metabolites and analogs
- Stable isotope labeled drugs, metabolites (2H;13C;15N, 18O)
- Process intermediates.
State-of-the-art organic synthesis laboratories contribute to high quality standards for your research programs. Our staff has experience in a wide range of synthetic chemistries and target molecules, including new chemical entities, analogs of lead compounds, drug standards, metabolites, narcotics, process intermediates, by-products and degradants. They are also a ready source of reference standards of generic compounds.
All the standards we produce are accompanied by a Certificate of Analysis.
Method Development, Feasibility & Validation
Method feasibility, development and validation support superior bioanalytical services. Covance uses dedicated scientists who have both the experience and expertise for robust method development. These methods are applied by a highly skilled technical staff trained in the use of the latest equipment.
With the ability to transfer methods among all of our facilities, our scientists routinely establish and validate over 100 proprietary and nonproprietary bioanalytical methods annually. Nonproprietary methods are published and are available as a reference.
Covance offers experience in nonclinical and clinical studies, expertise in rapid transition of methods between species, and trusted performance according to FDA Crystal City and ICH guidelines.
Nonclinical Toxicokinetic (TK) Studies
Toxicokinetic studies are performed in support of mammalian toxicology studies to correlate blood levels of drug with toxicity in the animal. We conduct comprehensive statistical data analysis using the industry standard WinNonLin™ and SAS™ and integrate our TK reports for ease of regulatory submission.
Pharmacokinetic (PK) Screening
Assessment of the pharmacokinetics of lead compounds early in the drug development cycle provides data that enables prediction of metabolism or PK in humans. Covance performs PK screening in rodents, dogs and monkeys prior to GLP studies in dedicated facilities.
Clinical PK/Bioavailability Studies
Covance conducts clinical bioavailability studies throughout the major stages of drug development. These studies measure the rate of distribution and elimination from the body, measure the amount of drug available at the therapeutic site and provide data that help establish appropriate dosage and dose frequency.
Bioequivalency Studies
Covance quickly and accurately performs studies that compare pharmaceutical equivalents or alternatives for the purpose of establishing equivalent extents and equivalent rates of absorption.
Therapeutic Drug Monitoring Studies
Covance Central Laboratory Services connection provides an integrated service, which reduces errors and allows for the coordination of sample shipments. This connection also provides chain-of-custody sample tracking and produces an integrated report for ease of regulatory submission.
Drug-Drug Interaction Studies
Covance's experienced technical staff offers rapid method development for comparator studies. Nonproprietary methods are published and updated frequently.
Immunoanalytical Services
Covance's immunochemistry services comprise a multidisciplinary team of specialized research and development scientists and highly trained scientific staff. The team integrates the capabilities of several laboratories to provide services using state-of-the art immunological and immunoassay techniques.
We offer a comprehensive range of techniques including EIA and RIA format immunoassays with spectrometric, fluorescence, beta emission and gamma emission endpoints providing the flexibility to accurately measure a wide range of compound types. With over a decade of experience in developing nonclinical and clinical methods from first principles, we have the demonstrated track record required to work with a diverse set of product candidates and their associated biomarkers.
Specialized Capabilities
Whatever your needs, Covance provides a variety of specialized capabilities, such as drug-drug interaction; antigenicity studies; bone metabolism; contraception; diabetes; estrogen replacement therapy; endocrinology; immune assessment; stress research; and protein/glyco protein analysis. |
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