How do pharmaceutical companies approach data from sexual health studies for regulatory agencies?
Article Abstract:
The process of bringing new drugs to market involves significant input from statisticians, not only through their involvement in clinical trial research but also through negotiations with regulators who provide guidance about the evidence necessary to convince government agencies, doctors, and patients that a particular drug is safe and effective for a particular disease. It is believed that only when a regulatory agency such as the Federal Drug Administration is persuaded that a drug is both safe and effective will it grant a license to market the drug.
Publication Name: Annual Review of Sex Research
Subject: Psychology and mental health
ISSN: 1053-2528
Year: 2005
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Sexual therapy in the age of pharmacotherapy
Article Abstract:
The effectiveness of combined medical and psychological intervention for the treatment of male sexual dysfunction is studied. Preliminary evidence indicates that combined treatment leads to improved efficacy of the medical interventions, decreased discontinuation rates, enhanced treatment and sexual satisfaction.
Publication Name: Annual Review of Sex Research
Subject: Psychology and mental health
ISSN: 1053-2528
Year: 2006
User Contributions:
Comment about this article or add new information about this topic:
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