02056nam a22002657a 4500 PH-MaWHO 20260212075707.0 260209b |||||||| |||| 00| 0 eng d 9241545224 WPRO Library eng UEJ.PJ.RB 1998 World Health Organization 641634 Guidelines for preclinical evaluation and clinical trials in osteoporosis Geneva : World Health Organization, 1998. 68 pages Osteoporosis and the fractures associated with the condition are a major cause of mortality and morbidity in ageing communities throughout the world, and many drugs for prevention and treatment are under development. Consensus is therefore needed on the principles and methods to be applied in clinical trials of the efficacy and safety of these novel drugs. The guidelines given in this book aim to provide a better understanding of how clinical trials in this field should be conducted. The book describes in detail the studies in laboratory and animal models that must be undertaken before any agent is considered for clinical trial in humans. It goes onto discuss the evidence-based principles underlying Phase I-IV studies, concentrating particularly on Phase III studies in the various types of osteoporosis. The guidelines are intended to be used by all those who are involved in the development and evaluation of interventions in the management of osteoporosis, including the pharmaceutical industry, drug regulatory authorities, and individual researchers. They offer a practical tool for use by WHO Member States and provide a framework on which national guidelines may be based. Osteoporosis Drug therapy 258411 Legislation, Drug 213751 Clinical trials Methods 649293 Evidence-based medicine Methods 437270 Guidelines 648758 https://iris.who.int/handle/10665/42088 MONO 2017 retain Mark 01-05-2018 14:48:34 nml 4168 4168 0 0 nml 0 0 WHO WPRO WPRO 2ndFlrLib 2021-05-23 0 UEJ.PJ.RB 1998 WPR000301 2024-01-24 00:00:00 2021-05-23 MONO