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Updated: May 19, 2026

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management
Yong Huang1, Robert Shi, Winnie Gee
1Drug Studies Unit, Department of Bioengineering & Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, CA 94143-0446, USA. yong.huang@ucsf.edu
Abstract:
Regulated drug bioanalysis (i.e., determination of drug concentrations in biological matrices for regulated studies) usually refers to animal toxicokinetics, bioavailability/bioequivalence and clinical pharmacokinetic studies. However, there is another important regulated drug bioanalysis - therapeutic drug management (TDM). In the USA, TDM is regulated by Clinical Laboratory Improvement Amendments. In this article, we review and compare human pharmacokinetic sample analysis and TDM sample analysis. The US FDA/Bioanalytical Method Validation Guidance and the American Association for Clinical Chemistry/TDM Roundtable Recommended Generic Assay Validation Guidance are also compared. Some regulated drug bioanalysis issues, such as terminology, validation concepts and acceptance criteria, are discussed. Fostering interaction between bioanalysts from pharmaceutical science and clinical chemistry and reducing the regulatory gaps between different agencies for drug bioanalysis is our objective.
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