This book is written as per Pharmacy Council of India regulations for pharmacy students. This book is student-friendly and suitable for BPharm and MPharm students for the subject of Industrial Pharmacy II (BPharm Semester VII), Pharmaceutical Regulatory Science (BPharm Semester VIII) and Regulatory Affairs (MPharm Semester I). It can also be used as a handy reference by the students of courses, apart from BPharm and MPharm, which have regulatory affairs and regulatory science in their curriculum.
This book presents essential information clearly, with suitable emphasis on the concrete aspects of each topic. This book is an essential resource for students pursuing careers in pharmaceutical research, development and manufacturing, providing them with the knowledge and tools needed to navigate the complex regulatory landscape and ensure compliance with regulations. Salient features of the book The content of this book is well organized in ten chapters and written in simple and easy to understand language. The entire text has been written in such a flow so as to cover all the three relevant subjects. This book covers the entire scope of pharmaceutical regulatory affairs including needs, significance, regulations and regulatory agencies. Chapters and topics are organized and named in accordance with the focus on pharmaceutical regulations and regulatory science. Important key learning points, common questions and useful references have given in each chapter. Inside you will find Pilot plant, SUPAC guidelines, post-marketing surveillance, technology transfer, quality risk management, regulatory authorities, drug development teams, new drug application, abbreviated new drug application, regulatory agencies, quality management systems, total quality management, quality by design, international organization for standardization, pharmaceutical regulatory agencies in India, new drug discovery and development, registration of Indian drug products in overseas market, DMF, CTD and its modules, clinical trials studies, good clinical practice, pharmacovigilance, and ICH guidelines.
Jigar Vyas MPharm,PhD,DN is Professor and Head,Department of Pharmaceutics,and Vice-Principal, Sigma Institute of Pharmacy, Vadodara,Gujarat.He is an alumnus of MS University of Baroda for BPharm (2002) and MPharm (2005). He qualified for GPAT (GATE then) with 92 percentiles in 2002 and 96 percentiles in 2003.He has to his credit more than 75 research and review papers published in national and international journals of repute and presented/guided more than 100 posters with winning ranks in many events. He has received a grant from SOIC (SSIP,GKS,GoG,Ahmedabad) for his postgraduate research scholar.He has published a book Molecular Pharmaceutics and Nanotech for MPharm students. Nensi Raytthatha MPharm is an Assistant Professor at Sigma Institute of Pharmacy and an alumnus of Gujarat Technological University for BPharm (2020,with GTU University top 10 rank) and MPharm (2022,with GTU University top 10 rank). She has a keen interest in research and development and teaching in pharmaceutics. She has to her credit more than 10 research and review papers, presented many posters, and participated in many SSIP pitching events for research grants. She is co-author in a book Molecular Pharmaceutics and Nanotech for MPharm students. Isha Shah MPharm is an Assistant Professor at Sigma Institute of Pharmacy and is an alumnus of Gujarat Technological University for BPharm (2020) and MPharm (2022,with GTU University top 10 rank).She has a keen interest in learning new things in pharmaceutics. She has to her credit more than ten research and review papers, presented many posters, and participated in many SSIP pitching events for research grants. She is a co-author in a book Molecular Pharmaceutics and Nanotech for MPharm students.
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