The objective of the bioavailability study is to estimate the blood plasma concentration (in ng/mcg level) of a particular drug with the help of sophisticated instruments involving HPLC. The authors of this book have tried to share their experiences in this field of technology and science. This book deals with the ethical issues involved in bioequivalence study as per DCGI (Drug Controller General of India, New Delhi) as well as FDA guidelines.
The concept of bioavailability and its study methodology in human volunteers have been discussed in detail with a special emphasis on protocol preparation, volunteer screening, informed consent, inclusion and exclusion criteria and study of pathological parameters prior to undertaking any bioequivalence study. Various methods of sample preparation and extraction of drug from plasma have been illustrated by different methods. The sophisticated techniques of solid phase extraction (SPE) system have been proved to be most simple, sensitive and time-saving. The different dimensions of its application and procedures have been highlighted. The procedures for evaluation of pharmacokinetic parameters (Cmax, Tmax & AUC) and their interpretation have been illustrated with methodical approach. The application of microdialysis in bioavailability study as well as ocular kinetics and drug delivery system of ophthalmic medicines have also been discussed in this book.
Prof. (Dr.) Tapan Kumar Pal, M.Ch.E. (Medalist), Ph.D. (Chem. Engg.), MIIChE (I), FIE, VDI (Germany), former DAAD Fellow is now Professor of Pharmaceutical Technology, Jadavpur University. A former student of Prof. R.N. Mukherjea, Dr. Pal started his research work in the field of adsorption and catalysis by molecular sieves zeolite. Afterwards Dr. Pal carried out his Ph.D. research in the Institut f r Chemische Technologie, Technische Hochschulle, Darmstadt, Germany under the invitation of German Academic Exchange Service (DAAD), during 1978-1981 where he worked with Prof. (Dr.) Fritz Fetting. As an exchange scientist, Dr. Pal had the opportunity to work with the eminent scientists like Dr. I. Sazbo, Dr. Endre Nagy and Dr. Guvicza Laszlo, Dr. Belafi K. Bako of Research Institute of Chemical Process Engineering, Koposvar University, Veszprem, Hungary. Dr. Pal has participated in many international symposia in India and abroad and edited two books including the present one. He has published more than 60 papers in Indian and foreign journals and he is also recipient of awards and honours. Dr. Pal is currently interested in the field of controlled release drug delivery system and bioavailability and bioequivalence study. Presently Dr. Pal is the Chief Investigator of Bioequivalence Study Centre, Jadavpur University, Kolkata. M. Ganesan, M.Pharm., is Asstt. Professor of Pharmaceutics, K.M. College of Pharmacy, Tamil Nadu. Mr. Ganesan has published 8 research papers in national and international journals. He has participated in many symposia and seminars as resource person. He has also participated and presented his research works in scientific conferences. He has guided 5 students for their M.Pharm. dissertation. He is a life-member of The Association of Pharmaceutical Teachers of India. He has carried out his doctoral research in the Quality Improvement Programme of AICTE under the guidance of Prof. (Dr.) T.K. Pal in the Department of Pharmaceutical Technology, Jadavpur University, Kolkata. He is also actively engaged in bioavailability and bioequivalence research in various capacities like pharmacokinetic expert, HPLC analyst and biostatistician in the Bioequivalence Study Centre, Jadavpur University, Kolkata.
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