BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

Issue link:

Contents of this Issue


Page 10 of 38

10 BioPharm International eBook July 2021 Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria 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 qualif ication and validation of analytical methods and bio- assays. This paper identif ies the relevant International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) guidelines and suggests appro- priate and efficient study designs, method of analysis, and acceptance criteria. Much of the guidance described in this paper is based on ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology (1), ICH Q9 Quality Risk Management (2), a nd USP G e ne ral C ha pte r <1033> " Biolog ic a l A s say Validation" (3). All study designs suggested are the min- imum number of determinations needed to qualif y or validate a method. Not all analytical methods are identical and different methods may or may not require all of the elements in this paper; however, for the most part, a quanti- tative or semi-quantitative method will require them. STUDY DESIGNS It is useful to break down the qualif ication/validation of an analytical method into six study designs. Sample THOMAS A. LITTLE, PhD,, is president of Bioassay Sciences. THOMAS A. LITTLE Biopharmaceutical Analysis Method Validation tilialucida -

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - July 2021 - BioPharm - July 2021 - Biopharmaceutical Analysis