Changing need for bioanalysis during drug development

Abstract

Recent years have witnessed the introduction of several high-quality review articles into the literature covering various scientific and technical aspects of bioanalysis, including chirality aspects. Now it is widely accepted that bioanalysis is an integral part of the pharmacokinetic/pharmacodynamic characterization of a novel chemical entity (NCE) from the time of its discovery and during various stages of drug development leading to its market authorization. There is a need for a comprehensive review article that takes into account the changing faces of bioanalysis from the time of inception of an NCE at the discovery stage and as the NCE moves forward in development. This review attempts to cover the versatility in the applicability of bioanalytical aspects with respect to the nature, rigor and available choices of analyses. For ease of understanding, bioanalytical aspects are discussed under sections covering discovery, preclinical and clinical stages. It is intended to give some general thoughts in this area which will form basis of a general framework as to how one would approach bioanalysis from inception (i.e. discovery of a lead molecule) and progressing through various stages of drug development.

Influence of number of calibration standards within a defined range on pharmacokinetic disposition—case studies with omeprazole and clopidogrel carboxylic acid

“…The importance of calibration curves, which is a primary driver for the validation parameters such as accuracy, precision and lower limit of quantitation, has been covered by previously published review articles (Srinivas, 2006;Srinivas, 2008). We were interested in exploring scenarios where one could reduce the number of non-zero calibration standards within the defi ned upper and lower limits of the calibration curve without compromising the end result of the quantitation (i.e.…”

Bioanalytical assay validation parameters re‐visited: perspectives on stability studies

“…Understandably, many recent reviews have emphasized the pivotal importance of bioanalysis to obtain accurate and high-quality pharmacokinetic data during the drug discovery and development process (Srinivas, 2006(Srinivas, , 2008Jemal and Xia, 2006;Wicremsinhe et al, 2006;Zhou et al, 2005).…”

Bioanalysis of complex clinical samples – considerations on analytical variability: some thoughts to ponder

“…The bioanalytical arena has tremendously grown in the last few decades with the introduction of scores of novel technologies, instruments, accessory tools and procedural nuances (Krone et al, 2010;Srinivas 2010;Wang et al, 2010;D'Souza et al, 2010, Ramanathan et al, 2010Jemal et al, 2010;Shimbo et al, 2009;Yu et al, 2009;Fonsi et al, 2008;Srinivas 2008). Added to this, the explosive technical versatilities of many platform technologies have enabled the development of complex and sensitive analytical method protocols for parent drugs and/or metabolites (Manjunath Swamy et al, 2010;Fonsi et al, 2008;Yao et al, 2008;Zang et al, 2005Zang et al, , 2007Basha et al, 2007;Zhang et al, 2007;Huang et al, 2006;Remane et al, 2010).…”