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.
Описание: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
Описание: Part I, "Drug Assessment and Regulation," is based on the nine sessions of the course that ranged in focus from recent developments in the science of clinical pharmacology and drug development to discussions of whether and how the regulation of drug development can (or should) be harmonized internationally.
Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.
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