Compendial testing methods are not required to be fully validated, but their suitability for
testing should be verified under actual conditions of use. This requirement is established in …

Bioanalytical methods are used to analyse an analyte in a biological matrix. Bioanalytical
method validation is the process of determining the suitability of the given bioanalytical …

Analytical method development should aim at delivering reliable measurements within a
given application. This implies that method validation is integrated in the development …

Joseph E. Knapp1, Scott VW Sutton2, Roger Dabbah3 and David A. Porter4* 1-Chair,
Analytical Microbiology Committee of Experts, USP 2-Vice-Chair, Analytical Microbiology …

Written for practitioners in both the drug and biotechnology industries, the Handbook of
Analytical Validation carefully compiles current regulatory requirements on the validation of …

The need to validate an analytical or bioanalytical method is encountered by analysts in the
pharmaceutical industry on an almost daily basis, because adequately validated methods …

Method validation has a long and productive history in the pharmaceutical and now,
biopharmaceutical industries, but it is an evolving discipline which changes with the times …

Scientists need analytical methods to measure elements, low molecular weight compounds,
and macromolecules in various matrices to support pharmaceuticals, environmental …

Workshop/Conference Report Bioanalytical Method Validation—A Revisit with a Decade of
Progress Page 1 Workshop/Conference Report Bioanalytical Method Validation—A Revisit with …