TEXT BOOK OF MODERN PHARMACEUTICS - According to latest syllabus of M.Pharm of Pharmacy Council of India(Paperback, Mr. Anupam Verma, Dr. Devendra Kumar, Prof. Shital Vijay Sirsat, Dr. Ritesh Kumar, Dr. Vivekanand Katare)
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Textbook of Modern Pharmaceutics is a comprehensive academic resource tailored to meet the advanced curriculum requirements of pharmaceutical sciences. The book begins with a detailed exploration of preformulation concepts, highlighting critical areas such as drug-excipient interactions, stability kinetics, and dispersion systems including emulsions, suspensions, and self-micro emulsifying drug delivery systems (SMEDDS). It also delves into the physiological and formulation considerations of small and large-volume parenterals, including their manufacturing and evaluation processes. A dedicated chapter on optimization techniques in pharmaceutical formulation introduces readers to key parameters and concepts of formulation optimization, along with practical insights into statistical tools like response surface methodology, contour designs, and factorial designs for effective product development. The section on validation comprehensively covers the principles of pharmaceutical validation, including types, regulatory perspectives, calibration protocols, and detailed insights into URS, DQ, IQ, OQ, and PQ, with emphasis on ICH and WHO guidelines. The book thoroughly addresses current Good Manufacturing Practices (cGMP), discussing objectives, policies, facility layout, equipment maintenance, and utility services to ensure compliance with regulatory standards. It also integrates the study of industrial management, covering production organization, materials handling, inventory and cost control, sales forecasting, and human relations—important elements for a holistic view of pharmaceutical production systems.