| About the Book:
"Bioequivalence Study of Drugs: Its Facilities and Techniques" is a comprehensive guide that explores the crucial concept of therapeutic equivalence between generic and innovator drug products. As the largest provider of generic drugs in the world, India faces a growing concern for the safety and efficacy of these products. This book provides a thorough understanding of Bioavailability and Bioequivalence Studies, offering valuable insights to pharmacists, doctors, and the pharmaceutical industry as a whole. The book details the process of establishing Contract Research Organizations (CROs) for conducting BA/BE studies, as well as key aspects of ethics committee approval, protocol, and procedure for reporting SAE. The practical guide also includes a detailed layout plan for CPU and bioanalytical labs, a list of essential instruments, and SOPs for conducting BA/BE studies. This book is an essential resource for those looking to advance their knowledge and expertise in the field of bioequivalence studies. |
| 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. |
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