Bioequivalence Studies

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Bioequivalence studies are some of the many laboratory services TGA Sciences provides to the Pharmaceutical, Biotechnology and Academic communities.

Bioequivalence studies assess the expected in vivo biological equivalence of two preparations or two similar types of a drug. If the two materials are thought to be bioequivalent it means that they would be expected to be the same. Studies can include in vivo and in vitro studies that measure the half life of the material through blood, urine, etc. According to the type of bioequivalence trial, suitable variables to be sampled are the concentration of the active ingredient and/or representative metabolites in blood, serum or plasma, or the amount excreted in the urine; another possibility is the measurement of pharmacological effects. TGA Sciences offers the flexibility of generating client specific bioequivalence studies to fit our client?s requirements.

About TGA Sciences

TGA Sciences, Inc. is a contract research organization (CRO) that provides its Pharmaceutical, Biotechnology and Academic clients a comprehensive range of laboratory services in support of basic research and development as well as for clinical studies. We offer a complete package of customized testing systems utilized in pre-clinical through Phase IV studies, including custom assay development, in vivo animal studies, cell-based assays, various immunological-based testing, as well as sample storage. We serve clients both in the U.S. and internationally.

All of our services are in compliance with cGLP and cGMP requirements. We are FDA registered, EMA Certified, AAALAC accredited, DEA licensed and USDA registered, and we have a comprehensive Quality System with a dedicated QA/QC Director to ensure that internal, customer and regulatory requirements are met.

To learn more about our services, request a quote or schedule an audit, please contact us using the form on the left, or contact Michael Settles at msettles@tgasciences.com or 781-393-6910 x203.