Clinical evaluation of psychotropic drugs for psychiatric disorders : principles and proposed guidelines
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Psychotropic medications have been dramatically successful over the since the 1950s, but severe problems remain. The World Health Organization (WHO) has a legal responsibility to review these drugs, estimate their benefit/risk ratio, help ensure their proper prescription and recommend which ones require international controls. This book utilizes the experience of the WHO to provide information about how such drugs should be evaluated, such as the planning, executing, monitoring, analyzing, interpreting and reporting involved with correctly making such evaluations. Subjects range from the evaluation of drugs from primary studies in healthy volunteers to the longitudinal study of drugs in routine use. Further chapters examine special issues in the evaluations of drug effects upon children and the elderly. There is also a section on study design and a final brief chapter on some transcultural issues.