A Textbook on GENERIC PRODUCT DEVELOPMENT for B. Pharmacy Students

About Author

This book is the collaborative effort of five accomplished academicians and researchers, each bringing their unique expertise and experience to the development of this comprehensive text on generic drug product development. Dr. T. Naga Aparna, with her extensive academic and research background in pharmaceutics, has played a key role in conceptualizing the overall structure of the book. Her insights into formulation design, stability studies, and dossier preparation have greatly enriched the depth and clarity of the content. She also led the editorial review process to ensure scientific rigor and academic quality. B. Deepthi contributed significantly to the sections related to dosage form development, analytical chemistry, and method validation. Her academic excellence and focused research in pharmaceutical chemistry helped shape the content to be both precise and practically relevant for students and professionals alike. Dr. Pittu Vishnu Priya brought her specialization in pharmaceutical biotechnology and her experience with regulatory submissions to the chapters on bioequivalence, scale-up studies, and the eCTD framework. Her contributions ensured that the book addresses both scientific and regulatory dimensions in a balanced manner. Dr. R. Prasanthi drew from her industry and academic background to contribute to the chapters on stability testing and exhibit batch execution. Her inputs bridged the gap between theoretical knowledge and practical implementation, enhancing the book’s real-world applicability. Dr. Perli Kranti Kumar, known for his expertise in analytical method development and regulatory affairs, contributed extensively to the sections on analytical validation, impurity profiling, and global drug approval processes. His guidance ensured that the content meets both academic and industrial standards, aligning with current regulatory expectations. Together, the authors have combined their strengths to develop a well-structured and informative resource that supports students, educators, and pharmaceutical professionals in understanding and applying the principles of generic drug product development and regulatory compliance.