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G. K. Jain
Accepted Abstracts: Drug Design
Rapid changes in both technology and market dynamics are currently coming into confluence and are exerting a major influence within the pharmaceutical industry. These changes have induced a revolution in drug discovery, and there is now increased focus on cost-benefit or pharmaco-economics in drug development, as the successful introduction of a new drug on to the market is not only an extremely costly and complicated process, but also fraught with a substantial risk of failure. Therefore, the ultimate goal has now become to reduce the drop-out rate of drug candidates in the latter, most expensive stages of drug development. The two most important questions in drug development are ?Has the right drug been selected?? and ?Has the optimal dose and dosage regimen been established?? Both questions can be addressed using an integrated PK/PD approach which has become a valuable scientific tool that helps developers select a rational dosage regimen for confirmatory clinical testing. Therefore, within the ?Rational Drug Discovery & Development?, ADME/DMPK field has assumed great significance and high relevance. Timely appraisal of all the factors impacting on the likely success of a drug candidate during pre-clinical, clinical and commercial phases of drug development has thus become extremely important and essential as it helps in reducing the rate of attrition during drug discovery and developmental phase. Advanced liquid chromatography and MS based sophisticated analytical/bio-analyitical tools and techniques play important role not only in establishing quality control/standardization/impurity profiling of new chemical entities and complex herbal chemotypes but also in quantification of drug candidates/drugs and their metabolites in biological fluids and tissues. These analyitical/bioanalytical tools when integrated with the predictive approaches provide precise and accurate quantification data that helps in deriving QC and DMPK parameters of NCEs, thereby contributing immensely towards drug discovery and development. Since DMPK profile, the toxicity and safety of drug candidates are the major contributors to high rate of attrition in drug development phase, minimal toxicity and good DMPK properties are essential for the clinical success of a drug candidate. In CDRI we have worked upon diversified biologically active chemical scaffolds as well as on therapeutically beneficial complex multi-component herbal chemotypes using liquid chromatography tandem mass spectrometry to derive their QC parameters and also to understand their DMPK properties. Our sole objective is to bring therapeutically potential NCEs and multi-component herbal chemotypes from bench to clinics.
Dr. G. K. Jain has completed his Ph.D at the age of 31 years from CDRI-Kanpur University and postdoctoral studies from Institute of Pharmaceutics, University of Bonn, Germany as a DAAD Fellow during 1983-85. He is scientist in Director?s Grade and Head Division of Pharmacokinetics & Metabolism, Central Drug Research Institute (CDRI), Lucknow, India. He has published more than 72 papers in reputed journals and has been granted more that 70 national/international patents. He has been associated CDRI?s drug discovery and development program for the last 20 years and had been instrumental in bringing several leads from bench to clinical trial level and then to clinic.