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Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Polymers for Pharmaceutical and Biomedical Applications: Fundamentals, Selection, and Preparation supports the successful selection, design, and development of polymers with the required properties and performance for a range of advanced pharmaceutical and biomedical applications. The book begins by introducing polymers for pharmaceutical and biomedical applications, examining classification, basic properties, structures, and grades. This is followed by in-depth chapters focusing on synthesis and modification, characterization techniques, and dissolution and solubility of polymers for pharmaceutical applications. Key applications are then highlighted, with chapters explaining in detail the preparation of polymers for conventional dosage, modified drug delivery, conjugates, advanced drug and gene delivery, medical devices, pharmaceutical packaging, tissue engineering, artificial organs, and dentistry. Throughout the book, the aim is to provide accessible, step-by-step coverage, supported by diagrams and case studies. Finally, safety and regulatory aspects are discussed. This is a valuable resource for all those who are newly approaching the field of polymers and product development for pharmaceutical and biomedical applications. This includes researchers and advanced students across polymer science, pharmaceutical science, biomaterials, biomedicine, healthcare, and chemistry, and scientists and R&D professionals in an industrial setting.
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