Industrial Pharmacy: From Pilot Plant to Market" is a comprehensive guide that provides practical approaches to pharmaceutical product development. With 37 exhaustive chapters, it covers important topics such as pilot plant scale-up techniques, technology transfer protocols, regulatory requirements, quality management systems, and Indian regulatory requirements. The book helps readers understand the significance of personnel requirements, space requirements, raw materials, and relevant documentation for solids, liquid orals, and semi-solids. It also provides insights into WHO guidelines for technology transfer, clinical research protocols, quality management concepts, ISO quality systems standards, and Indian regulatory requirements. This book is an essential resource for pharmaceutical professionals and students who seek to advance healthcare through innovative pharmaceutical product development.
Advanced Pharmacotherapeutics and Disease Management Why This Book? Comprehensive Coverage: Delve into the full spectrum of pharmacotherapeutics, from fundamental principles to advanced disease management strategies, ensuring a well-rounded understanding of the field. Practical Insights: Gain in-depth knowledge of drug mechanisms, therapeutic approaches, and clinical applications, all presented with clarity to enhance practical decision-making in patient care. Evidence-Based Practice: Stay updated with the latest clinical guidelines, research findings, and innovative therapies, ensuring your practice is aligned with current standards and advancements. Expert Guidance: Authored by seasoned academics, Prof. Krishna Mohan Chinnala and Dr. Muralidhar Rao Akkaladevi, the content is both authoritative and accessible, providing a robust and engaging learning experience for students and professionals alike.
Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics by Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi is an essential resource for M.Pharm, B.Pharm students, industry professionals, and regulatory experts. This book is meticulously structured into 20 comprehensive chapters, offering in-depth insights into critical areas of pharmaceutical regulatory affairs. Key topics include the clinical drug development process, with detailed coverage of phases from Phase 0 to Phase IV, as well as ethics in clinical research, exploring historical perspectives and modern ethical challenges. It also dives into regulations governing clinical trials across major regions like India, the USA, the EU, and Japan. Readers will find valuable information on USA, Australian, and European Union regulations, as well as emerging markets such as ASEAN, GCC, and CIS countries. The book also covers the regulatory aspects of drugs, cosmetics, herbals, biologicals, medical devices, and food and nutraceuticals. Topics like intellectual property rights (IPR) and quality management systems ensure readers are equipped with knowledge on patents, data exclusivity, and Total Quality Management. This guide also examines future trends in pharmaceutical regulatory affairs, offering insight into innovations and emerging regulatory practices. Ideal for professionals and students alike, this book serves as a vital reference in the global regulatory landscape.
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