A comprehensive guide to the essential industrial aspects of pharmaceutical manufacturing, this book takes readers through the entire journey of drug development, from pilot plant scale-up to regulatory approvals.
✔️ In-depth insights into scale-up techniques, technology transfer, and formulation challenges.
✔️ Expert analysis of Good Manufacturing Practices (GMP), Quality by Design (QbD), and regulatory compliance.
✔️ Detailed overview of Indian and international regulatory requirements, including CDSCO, FDA, and EMA guidelines.
✔️ Practical case studies and real-world applications to bridge the gap between theory and industry practices.
A must-have resource for students, researchers, faculty, and industry professionals, this book ensures a strong foundation in Industrial Pharmacy to navigate the highly regulated pharmaceutical sector with confidence.
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Dr. Kishore Babu, Dr.Kameswara Rao, Dr. Sushma
Dr.M.Kishore Babu is working as a Professor & Principal at QIS College of Pharmacy. He obtained his Ph.D-Pharmaceutical sciences from JNTU- Hyderabad.Dr.M.Kishore Babu Research interest includes Development of Novel Drug Delivery Systems, (oral, Transdermal etc.) Nano-technology (Ethosomes, Emulsomes, Solid Lipid Nano-Particles, Liposomes, Niosomes etc). Dr. M.Kishore Babu received grants from AICTE under various streams such as Industry- Institute Partnership Cell, RPS etc. He has guided 76 M.Pharm dissertations and has more than 80 National & International Peer-reviewed Journals with good citations to his credit.
Dr. Kameswara Rao Sankula is an Associate Professor in Pharmaceutics at Calcutta Institute of Pharmaceutical Technology & AHS, Uluberia, West Bengal. He has 12.6 years of academic experience and 2 years in the pharmaceutical industry (Biocon, Bangalore, Quality Control). He holds a Ph.D. from Acharya Nagarjuna University and has published 62 research and review articles. He has 06 granted patents, 06 Indian published patents, and 01 Canadian copyright.
Dr. Sushma N is an Assistant Professor in the Department of Pharmacy at KL College of Pharmacy, Koneru Lakshmaiah Education Foundation, Guntur, Andhra Pradesh. She has 2 years of academic experience and holds a Pharm.D from Priyadharshini Institution of Pharmaceutical Education and Research, affiliated with Acharya Nagarjuna University.
