USP Workshop—Topical & Transdermal Drug Products

Cosponsored by AAPS, this interactive workshop provided participants an opportunity to comment on and help share the direction of two proposed USP General Chapters (<3> and <725>) which published in Pharmacopeial Forum (PF) 35(3). The two General Chapters were part of a series of chapters that covered product quality and performance tests for the five routes of administration. The workshop helped to gather comments on the types and extent of testing to be included in a monograph and in vitro product performance tests.

Topics:

  • General Chapter <3> Topical and Transdermal Products—Product Quality Tests
  • General Chapter <725> Topical and Transdermal Products—Product Performance Tests
  • Establishment of a performance verification test (PVT)
  • Hydrocortisone cream as a PVT reference standard for equipment used to evaluate
    these products

When: September 14–15, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

Workshop Materials:

Participants: Professionals who work in or with

  • Topical or dermal products
  • The extent of testing to be included in a monograph
  • In vitro product performance tests
  • The establishment of a performance verification test (PVT) and the appropriateness of hydrocortisone cream as a PVT reference standard for equipment used to evaluate
    these products