Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria
Publication
Article
BioPharm InternationalBioPharm 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.
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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).
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Complex Biomolecules Require Analytical Evolution
Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Detecting Residual HCPs Demands a Holistic Approach
Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS
Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis
Prioritizing Cleaning Validation
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