FDAPerspectiveonGlobalEvaluationofFacialAcne.pptVIP

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FDAPerspectiveonGlobalEvaluationofFacialAcne.ppt

FDA Perspective on Global Evaluation of Facial Acne Brenda Carr, M.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA Outline Challenges to scale design Benefits of a common scale Attributes of a scale Examples of scales Challenges to Scale Design pleomorphic nature of acne variability in lesions variability in natural course what to assess Benefits of a Standard Scale Attributes of a Scale A limited number of levels Levels which are sufficiently described Levels which indicate the “clear” (no acne) and “almost clear” state Static measures to reflect a po

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