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.
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.
"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
