Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria

BioPharm International, BioPharm International, 2021 Biopharmaceutical Analysis eBook, Volume 2021 eBook, Issue 3
Pages: 10–14

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.

Read this article in BioPharm International’s July 2021 Biopharmaceutical Analysis eBook.

About the author

Thomas A. Little*, PhD, drlittle@bioassaysciences.com, is president of Bioassay Sciences.

*To whom all correspondence should be addressed

Article Details

BioPharm International
eBook: Biopharmaceutical Analysis, July 2021
July 2021
Pages: 10–14

Citation

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).