The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an intimate understanding of the mechanisms of pharmacokinetic and pharmacodynamic activity and the processes of drug evaluation is essential.
Clinical Trials of Drugs and Biopharmaceuticals provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with initiation of clinical trials. The sections focus on clinical assessments of drugs and biopharmaceuticals such as cardiovascular, respiratory, central nervous system, gastrointestinal and liver, genitourinary, skin, metabolism, and chemotherapeutic drugs as well as vaccines, biotechnology-derived therapeutics, and plant-based medicines.
Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved.
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Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen
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Hardcover. Zustand: new. Hardcover. Designing a drug development program can be a daunting task. Like its first edition, this text guides readers through successful design and implementation of all phases of clinical drug trials, as well as an overview of current procedures and issues involved in biopharmaceutical development. It includes updated chapters along with many new chapters and features, such as highlights of critical chemical and biological considerations in drug development. Written in a practical, informative way, this textbook provides a conceptual approach to and specific information about all four phases of clinical development prior to licensure, as well as for the design of post-marketing studies. Details how advances and demands for safety and efficacy have changed the process by which drugs are developed and approved. This work examines critical considerations for trials conducted during each phase of clinical development. It explores early pre-clinical evaluations of pharmacological activity and safety. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Bestandsnummer des Verkäufers 9780849321856
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