Role of pharmacokinetics in drug discovery & development

Speaker Profile

Dr Anisha Pargal Technology Head Consumer HealthCare Hindustan Lever Ltd

Dr Anisha Pargal received her B Pharm degree from Bombay University in 1979 and graduated with a Ph.D in Pharmacokinetics & Biopharmaceutics from Medical College of Virginia, Virginia Commonwealth University, USA in 1984.

She joined the Boots Research Centre, Mumbai on her return from USA, and set up their Pharmacokinetics & Drug Metabolism Department, responsible for conducting preclinical pharmacokinetic studies, phase 1 clinical trials and bioequivalence studies. In 1993, Dr Pargal joined the B.V. Patel Pharmaceutical & Research Development (PERD) Centre, Ahmedabad, as Joint Director, to help establish India’s first postgraduate multi disciplinary pharmaceutical research institute.

The PERD Centre developed excellent research facilities, and pioneered the concept of industry — academy interaction through continuing education and contract research, during her tenure. She was director of this institute from 1996-98. In 1999, Dr Pargal moved to AstraZeneca Research Centre in Bangalore to pursue and lead the basic drug discovery research programme in anti-infectives.

Dr Pargal currently heads the Technical function (Research, Formulation Development, Clinical evaluation & Manufacturing) for HLL’s new Consumer Healthcare business, and has been responsible for developing and launching the first multinational Ayurvedic FMCH brand – Lever Ayush.

Dr Pargal has been actively involved with the pharmacy profession. She is the Founder Secretary and Patron member of the Controlled Release Society, USA - India Chapter. During her tenure as Secretary the Society established itself as a leading Chapter in Asia. She has been the Scientific Convener for several years in succession, of the now well established Interna-tional Conference series on “Innovations in Pharmaceutical Sciences & Technology”, sponsored regularly by the B V Patel Education Trust. She is a member of the Editorial Board of the Indian Journal of Pharmaceutical Sciences and of the OTC committee of OPPI.

Synopsis

The role of pharmacokinetics is central to drug discovery, formulation design and development, toxicological understanding, clinical evaluation and optimisation of dosage regimens in therapy - processes that describe the drug molecule’s journey from the laboratory to the patient.

Pharmacokinetics (pharmac drug, kinetics-movement) is the science that describes “What the body does to the drug” and not ’What the drug does to the body”. In its simplest form, pharmacokinetics measures and correlates the time dependent concentration of drug and its metabolites in the body, body fluids and tissues, with the physicochemical properties of the drug and its pharmacological responses.

The concentration of drug and its metabolites in the body, body fluids and tissues is influenced by the physicochemical properties of the drug and the physiological body processes referred to as ADME, i.e absorption, distribution, metabolism and excretion. The latter can be influenced by age, gender, disease state and genetic and racial differences. The science of pharmacokinetics is a critical tool to help arrive at rationalised drug therapy and dosage forms, thus influencing clinical success and failure. In fact, it has been reported that 63 per cent of all preclinical compounds nominated for clinical development fail due to poor pharmacokinetics and toxicological properties.

This presentation will exemplify the role of pharmacokinetics in preclinical drug discovery, human clinical trials, design of novel controlled drug delivery systems and the significant role this science has played in the evolution of regulatory mechanisms for the generic pharmaceutical industry, in the last decade.