1 / 6

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.

micheal
Télécharger la présentation

Topical Dosage Forms Classification/Nomenclature

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related