Bioequivalence Study of Drugs: Its Facilities and Techniques

This book has been designed to illustrate the concept and practice of Bioavailability and Bioequivalence Studies and will definitely beneficial to them who are interested to proceed further in this field. India is the largest provider of generic drugs globally. Availability of the generic products in the market has been gained serious public consideration in respect of their safety and efficacy with the innovator products. Bioequivalence (BE) studies with a view to demonstrate therapeutic equivalence between two drug products (test and reference or innovator) can able to answer this public concern internationally. The aspect of bioequivalence study is not included in the syllabus of pharmacy or MBBS, this will be definitely helpful to the pharmacist, doctors and the pharma industries to have a thorough knowledge regarding this subject as well as it will guide them to establish a Contract Research Organizations (CRO) for conducting BA/BE study. Moreover it is obvious that the technology transfer from existing CROs for conducting BA/BE study is not possible due to commercial reason. In our book attempts were made to elaborate the CPU and the bioanalytical labs with specimen layout plan, list of essential instruments, and list of SOPs for conducting BA/BE studies etc. Prior to any study the approval of ethics committee is mandatory. Procedure of getting the approval along with the composition of ethics committee has been highlighted. The contents of protocol to conduct BA/BE study including ICF, CRF, PIS, IB, IU and preclinical study of volunteers along with procedure for reporting SAE have been discussed in details. Contents: 1. Introduction 2. Essential Components required for BA/BE Study Centre 3. Ethical Perspectives 4. Pre-requisites for Conducting BA/BE Studies 5. Methods to Conduct BE Study 6. Contents of a BE Study Report 7. Summary 8. LC-MS/MS Instrumentation 9. References & Appendices About the Authors: Bhaswati Pal, MBA, Ph.D had completed her Bachelor in Business Administration in HR studies from West Bengal University of Technology and Masters in Business Administration & Doctorate in Clinical Research from Indian School of Business Management, Mumbai under Stamford University, Hong Kong in 2012 and 2018 respectively. Since 2009 she had been working with TAAB Biostudy Services, as a Senior Executive &Team Leader, HR. Presently she is one of the Managing Partners of TAAB Biostudy Services. Shubhasis Dan, M. Pharm, Ph.D joined as a Research Scholar (UGC-BSR Meritorious Fellow) in the Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University. Being a pharma post graduate (M. Pharm), he completed his doctoral research under guidance of Prof.T K Pal and awarded in Ph.D from Jadavpur University in 2017 with a good number of National and International publications. He is working with a CRO (CDSCO approved BA/BE Study Centre) since 2011, which results in better understanding of clinical regulatory as well as its implementations inside of the organization towards ensuring the smooth functioning. Dr. Dan is presently associated with TAAB Biostudy Services, Kolkata as a Team Leader, Clinical Studies and Regulatory Affairs with an obligation to interact with disciplinary groups form the Sponsor, Regulators as well as Ethics Committee personals. Tapan Kumar Pal, M. ChE (Gold Medalist), F.I.E, VDI (Germany), Former DAAD Fellow (Germany), Former Professor and HOD, Department of Pharmaceutical Technology, Jadavpur University is now attached to the same university as Emeritus Medical Scientist (ICMR). He had the opportunity to work with the eminent scientists Prof. (Dr.) Fritz Fetting in Germany as well as Dr. Endre Nagy, Dr. (Mrs.) Belafi K Bako, Dr. I. Salso and Dr. G. Laszlo of Hungary. Prof. Pal has been able to publish more than 170 research papers in various National & International Journals and 51 students have been awarded Ph. D degree under his supervision. He founded the Bioequivalence Study Centre, Jadavpur University in 2002, the then only BA/BE Study Centre in eastern India approved by the CDSCO, Govt. of India.