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Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.
A critical element in all drug development—from early clinical trials to final form and dose of a drug—is the qualification and validation of analytical methods and bioassays.
This paper identifies the relevant International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) guidelines and suggests appropriate and efficient study designs, method of analysis, and acceptance criteria. All study designs suggested are the minimum number of determinations needed to qualify or validate a method.
Thomas A. Little*, PhD, firstname.lastname@example.org, is president of Bioassay Sciences.
*To whom all correspondence should be addressed
eBook: Biopharmaceutical Analysis, July 2021
When referring to this article, please cite it as T.A. Little, “Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria," BioPharm International Biopharmaceutical Analysis eBook (July 2021).