Abstract

DESIGN OF EXPERIMENTS FOR ANALYTICAL METHOD AND VALIDATION

Heena Ninama*, Dr. Chainesh Shah and Dr. Umesh Upadhyay

Abstract

Design of experiment is a powerful and underutilized development tool for method characterization and method validation. Analytical professionals need to be comfortable using it to characterize and optimize the analytical method. If used properly and during development, DOE will provide significant improvements in precision and a reduction in bias errors. It will further help to avoid costly and time-consuming validation studies as concentrations are modified in formulations and dosing schemes are changed for drug product and drug substance. A systematic appíoach foí using DOE foí analytical method development and validation is discussed in this papeí and was wíitten in line with the Inteínational Confeíence of Haímonization (ICH) Q2(R1), Q8(R2), and Q9 guidelines (1-3). A quantitative undeístanding of the factoís that influence íesolution, lineaíity, píecision, and accuíacy is integíal to applying DOE to method development.

Keywords: pre-clinical phase, Pharmacokinetic parameters, Safety assessment, analytical techniques, Stability; Precision; Accuracy; SOP.