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Topical Dosage Forms Classification/Nomenclature

Topical Dosage Forms Classification/Nomenclature. Advisory Committee of Pharmaceutical Science Meeting March 12, 2003 Yuan-yuan Chiu, Ph.D. ONDC/OPS/CDER/FDA. Objective.

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Topical Dosage Forms Classification/Nomenclature

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  1. Topical Dosage FormsClassification/Nomenclature Advisory Committee of Pharmaceutical Science Meeting March 12, 2003 Yuan-yuan Chiu, Ph.D. ONDC/OPS/CDER/FDA

  2. Objective • To develop a clear, concise, and science-based classification (nomenclature) system for topical dosage forms where the existing system is not adequate

  3. Scope • Dermatological topical administration • Dosage forms included: Liquid emulsion, semi-solid emulsion, and semi-solid suspension • Lotion, Cream, Ointment, Paste, and Gel • Dosage forms excluded: Solution, liquid suspension, powder, aerosol (including foams)

  4. Steps Taken • Identified current practices in labeling and specifications at FDA and USP • Reviewed properties and formulations of approved NDA/ANDA drugs • Clarified with CDER medical staff any efficacy significance associated with definitions of topical dosage forms • Consulted textbooks and literature • Evaluated OTC and NDA/ANDA drugs for physical properties in CDER laboratory

  5. Agenda • Introduction Yuan-yuan Chiu, Ph.D. • Remarks from a Medical Perspective Jonathan Wilkin, M.D. • FDA Laboratory Data Lucinda Buhse, Ph.D. • FDA Proposal - Definitions and Decision Tree Chi-wan Chen, Ph.D. • USP Nomenclature for Topical Dosage Forms Herb Carlin, Ph.D. • Questions to Committee Yuan-yuan Chiu, Ph.D.

  6. Contributors to the Project • Daniel Boring Lucinda Buhse • Chi-wan Chen Yuan-yuan Chiu • Wilson DeCamp James Fan • Mamta Gautam-Basak Charles Hoiberg • Gil Jong Kang Hon Sum Ko • Richard Kolinski Markham Luke • Lisa Mathis Moheb Nasr • Saleh Turujman Benjamin Westenberger • Jonathan Wilkin Anna Wokovich

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