Sex Differences in Drug Development

نویسندگان

  • A. C. Mattison
  • Faye
  • D. R. Mattison
چکیده

The premise of individualized or personalized medicine is that the intervention is tailored to the individual. Individualized therapy will accommodate differences in body size, differences in metabolism and elimination, as well as differences in response. One appropriate starting point for individualized therapy is to focus on sex differences. Men and women differ in critical molecular, genetic, cellular, and physiological aspects. One important consequence of these differences is how sex influences drug disposition and impact. While, historically, women were excluded from most clinical studies, more recently there have been attempts to include them as subjects in all aspects of drug development. Additionally, more attention is being directed to sexappropriate diagnosis and treatment of disease as a component of individualized medicine. Despite this Sex Differences in Drug Development A. C. Mattison Faye, D. R. Mattison increased attention to sex differences, there remain substantial gaps in our understanding of sex differences in drug development, the focus of this review. This review was adapted from a talk presented at the Second International Congress of Gender Medicine in Vienna in 2007. Kurzfassung: Die Voraussetzung für individualisierte oder personalisierte Medizin ist der Zuschnitt der Behandlung auf das Individuum. Individualisierte Therapie berücksichtigt Unterschiede bei Körpergröße, Metabolismus und Medikamentenausscheidung sowie unterschiedliches Ansprechen. Ein geeigneter Ansatzpunkt für individualisierte Therapie ist der Fokus auf Geschlechtsunterschiede. Männer und Frauen unterscheiden sich kritisch in molekularer, genetischer, zellulärer und physiologischer Sicht. Eine wichtige KonseFrom the Obstetric and Pediatric Pharmacology Branch, Center for Research for Mothers and Children, National Institute of Child Health & Human Development, National Institutes of Health, US Department of Health & Human Services Correspondence: Donald R Mattison, MD, Obstetric and Pediatric Pharmacology Branch, Center for Research for Mothers and Children, National Institute of Child Health & Human Development, National Institutes of Health, 6100 Executive Blvd, Rm 4A01, Bethesda, MD 20892, USA; E-Mail: [email protected] quenz dieser Unterschiede ist, wie das Geschlecht die Anwendung von Medikamenten und deren Wirkung beeinflusst. In der Vergangenheit waren Frauen von den meisten klinischen Studien ausgeschlossen, in den vergangenen Jahren wurden Versuche unternommen, sie in Medikamentenentwicklungsstudien einzuschließen. Zusätzlich wird mehr Aufmerksamkeit auf geschlechtsangepasste Diagnose und Behandlung als Teil der individualisierten Medizin gelegt. Trotz der steigenden Beachtung von Geschlechtsunterschieden bleiben weitreichende Diskrepanzen in unserem Verständnis von Geschlechtsunterschieden in der Entwicklung neuer Medikamente, worauf diese Übersicht eingehen wird. Diese Übersichtsarbeit ist die Fortführung einer Präsentation am Second International Congress of Gender Medicine, der im Juni 2007 in Wien stattfand. Blickpunkt DER MANN 2008; 6 (1): 21–5.

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تاریخ انتشار 2016