Day 1: Wednesday, March 12, 2003

Topical Dermatological Drug Product Nomenclature

Topical dosage from definitions from the CDER Data Standards Manual

Topical dosage form definitions from USP <1151> Pharmaceutical Dosage Forms

Decision Tree

Proposed Definitions for Topical Dosage Forms

Questions to the Advisory Committee

Gupta, P., Garg, S., “Recent Advances in Semisolid Dosage Forms for Dermatological Application”, Pharm. Tech., March 2002, p. 144-162 (even pages only).

Aulton, M.E. (ed) (2002), Pharmaceutics: The Science of Dosage Form Design, 2^nd Edition. Formulation of Dermatological Vehicles, p. 528-531

Gennaro, A.R. (ed) (2000), Remington:The Science and Practice of Pharmacy, 20^th Edition.

Gel and Lotions: p. 745-748

Ointments: p.845-848

Other Medicated Applications: p.856

Lieberman, H.A., Rieger, M.M., Banker, G.S. (eds)(1996), Pharmaceutical Dosage Forms: Disperse Systems, Volume 2.

Chapter 5: Topical Suspensions p. 183 – 207

Chapter 10: Gels p. 399-411

Lieberman, H.A., Rieger, M.M., Banker, G.S. (eds)(1988), Pharmaceutical Dosage Forms: Disperse Systems, Volume 1.Chapter 6: Pharmaceutical Emulsions p. 199 – 203, p. 217-219, p.232-236

Topical Dermatological Bioequivalence Methods Development

Comparability Protocols

Draft Guidance for Industry: Comparability Protocols - Chemistry, Manufacturing and Controls Information. February 2003. <http://www.fda.gov/cder/guidance/5427dft.pdf>

Day 2: Thursday, March 13, 2003

Research in OPS

Rapid Response Fact Sheet

Dose Content Uniformity Parametric Tolerance Interval Test for Aerosol Products

Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Chemistry, Manufacturing, and Controls Documentation, October 1998. <http://www.fda.gov/cder/guidance/2180dft.pdf>

Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentation, July 2002. <http://www.fda.gov/cder/guidance/4234fnl.pdf>

10. Content Uniformity Test, The Japanese Pharmacopoeia, Thirteenth Edition, April 1996, p. 25

Williams, RL , WP Adams, G Poochikian, and WW Hauck. Content Uniformity and Dose Uniformity: Current Approaches, Statistical Analyses, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products. Pharm Res, 2002; 19:359-66.

Olsson, B. and D Sandell. Delivered Dose Uniformity Testing: IPAC-RS Advocacy and Justification. Respiratory Drug Delivery VIII Proceedings, 2002, Vol. I, pp. 115-22.

Hauck, W. An Independent Assessment of IPAC-RS’ Proposal. Respiratory Drug Delivery VIII Proceedings, 2002, Vol. I, pp. 123-7.

IPAC-RS. A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products. 15 November 2001.

Bioequivalence of Endogenous Drugs