10 BioPharm International eBook July 2021 www.biopharminternational.com
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, drlittle@bioassaysciences.com, is president
of Bioassay Sciences.
THOMAS A. LITTLE
Biopharmaceutical Analysis Method Validation
tilialucida
-
Stock.adobe.com
