IP Innovative Publication Pvt. Ltd.
IP Innovative Publication Pvt. Ltd.
The authors of "Text Book of Pharmaceutical Regulatory Science" are Prof. (Dr.) Ravinesh Mishra, Dr. Bhartendu Sharma, Dr. Priya Sharma.
If you want to download the PDF of Text Book of Pharmaceutical Regulatory Science, it is not allowed. However, you can immediately access the book by purchasing the ePub with a % discount.
If you want to download a Free PDF of Text Book of Pharmaceutical Regulatory Science, it is not allowed. However, you can immediately access the book by purchasing the ePub with a % discount.
“Text Book of Pharmaceutical Regulatory Science” is a comprehensive guide that explores the principles, practices, and evolving landscape of pharmaceutical regulations governing the development, approval, manufacturing, and marketing of pharmaceutical products. This book is designed to bridge the gap between regulatory theory and practical application, making it an essential resource for students, academicians, researchers, and professionals in the pharmaceutical industry. By integrating foundational concepts with contemporary regulatory challenges, it serves as a vital tool for understanding the complex and dynamic field of drug regulation.
The book covers a wide array of topics, beginning with an in-depth examination of the drug development process—from preclinical research to post-marketing surveillance. It provides a thorough analysis of regulatory frameworks in India, including the Central Drugs Standard Control Organization (CDSCO), as well as international regulations such as those enforced by the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH) guidelines. Additionally, the text delves into critical aspects of intellectual property rights (IPR), patent laws, and regulatory exclusivity, which are crucial for protecting innovations in the pharmaceutical sector.
Quality assurance (QA) and quality control (QC) in pharmaceutical manufacturing are discussed in detail, emphasizing Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). The book also explores the design, execution, and ethical considerations of clinical trials, along with the growing importance of pharmacovigilance in monitoring drug safety post-approval.
With clear explanations, illustrative case studies, and real-world examples, this book aims to equip readers with the knowledge and skills required to navigate regulatory environments effectively. Whether preparing for regulatory examinations, engaging in research, or ensuring compliance with global standards, this text serves as an indispensable reference for anyone involved in the pharmaceutical and life sciences industries. Its practical approach ensures that readers not only understand regulatory requirements but also learn how to apply them in real-world scenarios, fostering excellence in pharmaceutical regulatory science.
Prof. (Dr.) Ravinesh Mishra is currently working as Dean, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. He holds a B.Pharm. from CCS University (2003), M.Pharm. from Rajiv Gandhi University of Health Sciences, Bengaluru (2007), and Ph.D. in Pharmaceutical Sciences from Jamia Hamdard University, New Delhi (2011). With over 18 years of professional experience, Prof. Mishra has qualified GATE twice and was awarded the UGC and CSIR fellowships during his doctoral studies. He received the prestigious DST Young Scientist Award in 2010 and has also undergone short-term toxicological training at AIPT, USA. Prof. Mishra has made significant contributions to pharmaceutical research with over 70 publications, 10 patents, 2 books, and 10 book chapters to his credit. He has guided several M. Pharm students and Ph.D. scholars. His achievements have been recognized with awards from the Society of Toxicology and Therapeutic Drug Monitoring & Clinical Toxicology.
Dr. Bhartendu Sharma is currently working as an Associate Professor, Head of Department, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. He holds M.Pharm in Pharmaceutical Chemistry and earned his Ph.D. in Pharmaceutical Sciences, bringing with him over 13 years of academic and research experience. Dr. Sharma has been actively involved in both teaching and research, contributing to the development of future pharmaceutical professionals. His areas of interest include drug design and synthesis, medicinal chemistry, and pharmaceutical analysis. He has guided numerous undergraduate, postgraduate and Ph.D. scholars and is committed to fostering research-oriented learning. Over the years, he has contributed to several research publications in reputed journals and has participated in various national and international conferences. Dr. Sharma is dedicated to academic excellence, innovation in pharmaceutical education, and continuous professional development.
Dr. Priya Sharma is currently working as an Assistant Professor, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. She holds M.Pharm in Pharmaceutics and earned her Ph.D. in Pharmaceutical Sciences. With over 5 years of academic and research experience, she is actively involved in both teaching and guiding students in the field of pharmaceutical sciences. Her core areas of interest include novel drug delivery systems, formulation and development, and pharmaceutical technology. She has participated in several national/international conferences and workshops, and is committed to continuous learning and innovation in pharmaceutical education. Dr. Sharma has also contributed to research publications and is keen on expanding her research profile through interdisciplinary collaborations.
At IP Innovative Publication, we also offer a collection of insightful and thought-provoking books covering a wide range of subjects. Our books are authored by experts and researchers in their respective fields, providing valuable knowledge and perspectives to readers.
2025 © All rights reserved by 🔗 IP Innovative Publication Pvt. Ltd.
