About book : A Textbook of Pharmaceutical Regulatory Science" is a comprehensive resource tailored for students and professionals in the pharmaceutical field, particularly those pursuing a Bachelor of Pharmacy (B. Pharm) degree. The book aligns with the Pharmacy Council of India's syllabus for the eighth semester, ensuring relevance to current academic standards. Key Features: Structured Content: The textbook is organized into five units, each encompassing one to two chapters. Topics include New Drug Discovery and Development, Regulatory Approval Processes, Clinical Trials, and Regulatory Concepts. Purpose: This textbook aims to provide a clear and concise understanding of pharmaceutical regulatory science, making it accessible to students and professionals. It is a valuable guide for those preparing for examinations or seeking to enhance their knowledge in this specialized area.

About author : Mr. G. Dileep Kumar: Mr. Dileep Kumar Garnipudi has completed his B. Pharmacy from Acharya Nagarjuna University and M. Pharmacy in Pharmaceutics from Acharya Nagarjuna University. Later, He worked for 5 years as an assistant professor at St. Ann’s College of Pharmacy. Chirala, Andhra Pradesh, is an Assistant Professor in the Pharmaceutics department at RAI University, Ahmedabad. He is also a research scholar at Mohan Babu University, Tirupati. The Avishkar Foundation awarded him the Best Young Teacher of the Year award in 2024. To his credit, He has three international research publications and attends many national seminars, Webinars, FDP, and Workshops. Dr. Mekala Sunil: Dr Mekala Sunil, M. Pharm., PhD, is a Professor and Principal at Dr Anji Reddy College of Pharmacy, Piduguralla, Palnadu, A.P, India. He obtained his B. Pharm degree from Jawaharlal Nehru Technological University Kakinada, M. Pharm in Pharmaceutics specialization from Acharya Nagarjuna University Guntur and Ph. D from JNU. Dr. Mekala Sunil has 12 years of teaching and research experience. He has published 38 research articles in peer-reviewed, internationally indexed, impact journals. He has presented nine papers/ posters at various international conferences. He has 1 Indian Design Patent and 1 UK Design Patent. He has supervised 20 undergraduate and 11 postgraduate research projects. He is a reviewer of various reputed journals. He is a life member of the Society of Pharmaceutical Education & Research (SPER). He is a recipient of Andhra Pradesh Guru Spandana Puraskar-2022. Dr. Samson Israel: Dr. Samson Israel, working as a professor at St. Ann College of Pharmacy, wishes to share the knowledge acquired over 15 years of teaching and research experience gained over the globe with more than 22 research publications in various National and International journals, two books and 3 paten