Author: United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug ProductsPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 16
Book Description
Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis
Author: United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug ProductsPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 16
Book Description
Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis
Author: Guidelines for Clinical Evaluation of Agents Used in the Treatment Or Prevention of Osteoporosis
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 9
Book Description
Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention Or Treatment of Postmenopausal Osteoporosis
Author: United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug ProductsPublisher:
ISBN:
Category : Osteoporosis
Languages : en
Pages : 20
Book Description
Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis
Author: World Health OrganizationPublisher:
ISBN: 9789241545228
Category : Medical
Languages : en
Pages : 68
Book Description
This book provides comprehensive guidelines for the design, implementation, and interpretation of preclinical studies and clinical trials of agents undergoing investigation for the management of osteoporosis. Noting the magnitude of the public health problem caused by osteoporosis and related fractures, the book responds to the urgent need for a cohesive and rational approach to the search for new therapeutic or preventive agents. Recommended principles and methods reflect the consensus reached by a large number of international experts, representatives of the pharmaceutical industry, and drug regulatory authorities. The book opens with a brief discussion of the current and future public health problem caused by osteoporotic fractures, followed by conceptual and operational definitions of osteoporosis and a recommended classification of four intervention categories that facilitate the definition of treatment objectives and the design of targetted studies. Against this background, the next chapter offers a detailed guide to the aims, design, conduct and interpretation of preclinical studies. Specific recommendations are given for the selection of in vitro and animal models, the design of the study, including dose ranges and duration of treatment, and the most appropriate end-points for assessing efficacy. The most extensive chapter provides a comprehensive description of basic principles and methods to follow during clinical trials. Information ranges from a discussion of problems with the use of bone mineral density to predict fracture risk, through advice on the choice of tests and techniques for measuring the effects of interventions, to a discussion of general principles of trial design, including selection of study population, treatment regimen, duration of studies, sample size, and frequency of measurement. Drawing on these detailed principles and methods, subsequent chapters offer concise guidance specific to phase I and phase II studies, phase III studies in severe osteoporosis, phase III studies in osteoporosis without fragility fractures, and phase III studies in osteopenia. The book concludes with chapters outlining principles and methods for phase III clinical trials in subjects with normal bone mass, and for phase IV studies.
Osteoporosis in Men
Author: Eric S. OrwollPublisher: Academic Press
ISBN: 0080923461
Category : Medical
Languages : en
Pages : 764
Book Description
Since the publication of the first edition, the U.S. Surgeon General released the first-ever report on bone health and osteoporosis in October 2004. This report focuses even more attention on the devastating impact osteoporosis has on millions of lives. According to the National Osteoporosis Foundation, 2 million American men have osteoporosis, and another 12 million are at risk for this disease. Yet despite the large number of men affected, the lack of awareness by doctors and their patients puts men at a higher risk that the condition may go undiagnosed and untreated. It is estimated that one-fifth to one-third of all hip fractures occur in men. This second edition brings on board John Bilezikian and Dirk Vanderschueren as editors with Eric Orwoll. The table of contents is more than doubling with 58 planned chapters. The format is larger – 8.5 x 11. This edition of Osteoporosis in Men brings together even more eminent investigators and clinicians to interpret developments in this growing field, and describe state-of-the-art research as well as practical approaches to diagnosis, prevention and therapy. Brings together more eminent investigators and clinicians to interpret developments in this growing field Describes state-of-the-art research as well as practical approaches to diagnosis, prevention and therapy There is no book on the market that covers osteoporosis in men as comprehensively as this book
General Considerations for the Clinical Evaluation of Drugs
Author: United States. Food and Drug Administration. Bureau of DrugsPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
Book Description
Guidelines for the Clinical Evaluation of Radiopharmaceutical Drugs
Author: United States. Food and Drug Administration. Division of Oncology and Radiopharmaceutical Drug ProductsPublisher:
ISBN:
Category : Radioisotopes
Languages : en
Pages : 24
Book Description
Guidelines for the Clinical Evaluation of Radiopharmaceutical Drugs
Author: United States. Food and Drug Administration. Bureau of DrugsPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 24
Book Description
General Considerations for the Clinical Evaluation of Drugs in Infants and Children
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Chemotherapy
Languages : en
Pages : 28
Book Description