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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

Topical Dosage FormsClassification/Nomenclature

Advisory Committee of Pharmaceutical Science Meeting

March 12, 2003

Yuan-yuan Chiu, Ph.D.

ONDC/OPS/CDER/FDA

objective
Objective
  • To develop a clear, concise, and science-based classification (nomenclature) system for topical dosage forms where the existing system is not adequate
scope
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)
steps taken
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
agenda
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.
contributors to the project
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