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Zusatztext "This book is useful because it consolidates information from preclinical and clinical fields and also adds the perspective of regulatory agencies in bringing drugs to market?definitely is more ambitious than the previous edition." -Alan Poisner! M.D.! Doody's Book Review Service "This volume 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 the initiation of clinical trials. ? 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." - In Anticancer Research! Vol. 26! 2006 Informationen zum Autor Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen Klappentext Based on the bestselling Handbook of Phase I/II Clinical Drug Trials! this newly named! completely revised and expanded volume details how recent advances and increasing demands for safety and efficacy have changed the process by which drugs are developed and approved. It examines critical considerations for trials conducted during each phase of clinical development. It also explores early pre-clinical evaluations of pharmacological activity and safety. Ten sections examining clinical assessment are organized according to anatomical targets (e.g. CNS! liver)! functions (e.g. metabolic! chemotherapeutic) with another section covering vaccines! biotechnology-derived therapeutics! and plant-based medicines. Zusammenfassung 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. Inhaltsverzeichnis Preparation for Clinical Trials Drug Discovery and Preclinical Research! C.-J. Lee! L.H. Lee! C.L. Wu! and B.R. Lee The Pharmaceutical Background! S.C. Valvani The Pharmacological Background for Drug Evaluation! L.H. Lee! C.L Wu! B.R. Lee! and C.-J. Lee Animal Tests as Predictors of Human Response! P.I. Folb Regulatory Organization and Decision Making Worldwide Regulatory Agencies! C.-J. Lee! L.H. Lee! C.L.Wu! B.R. Lee! and M.-L. Chen Decision Points in Drug Development! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Management of Clinical Development Costs! M. Hovde Ethical Aspects and Good Clinical Practice! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Investigational New Drug Application and the Licensure Approval Process! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Clinical Trials from Phase I to Phase IV! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Evaluation anad Quality Assurance of Drugs and Biopharmaceuticals The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation! P.E. Rolan and V. Molnar Drug Interactions! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Assessment of Cardiovascular Drugs Antianginal Drugs! N.C. Pauly Antihypertensive Drugs! W.S. Waring and D.J. Webb Drugs for Treatment of Stroke! M. Soehngen! W. Soehngen! and Y. Al-Rawi Assessment of Respiratory Drugs Antiasthmatic Drugs! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Assessment of Central Nervous System Drugs Anxiolytics and Hypnotics! G.R. McClelland and G. Moroz Antidepressants! L.H. Lee! C.L. Wu! B.R. Lee! and C.-J. Lee Drugs for Alzheimer 's Disease and Other Dementias! B.R. Lee! L.H. Lee! C.L. Wu! and C.-J. Lee A...
