About Author: Kale Vishal Bibhishan
Department Of Pharmacy, School Of Chemical Engineering and Bio-Technology
SASTRA UNIVERSITY, Thanjavur-613402, Tamil Nadu, INDIA
Reference ID: PHARMATUTOR-ART-1064
Abstract
Pre-clinical phase is a laboratory test of a new drug on animal subjects, conducted together evidence justifying a clinical trial. For those drugs which are in clinical phase, method development requires various pre-clinical bioanalytical support parameters. Bioanalytical support plays a pivotal role in answering a series of questions concerning the toxicity, pharmacokinetic parameters, safety assessment, formulation optimization .Once method development process was initiated one should know the different techniques of sampling, handling, sample preparation methods that are suitable and problems in it. After sample preparation, suitable analytical techniques have to be selected for method development. The developed method now have to be validated, for this, Initially “Analytical Instrument Qualification” has to be performed which includes four main phases- Design qualification, Installation qualification, Operational qualification and Performance qualification. Method is said to be validated when all considered validation parameters like linearity, specificity, selectivity etc are within the limits. Thus the method is developed and validated for a drug in preclinical phase using analytical technique of suitable sensitivity and selectivity.