Advisory Committee for Pharmaceutical Science
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
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).
Gennaro, A.R. (ed) (2000), Remington:The Science and Practice of Pharmacy, 20th Edition.
Gel and Lotions: p. 745-748
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
Draft Guidance for Industry: Comparability Protocols - Chemistry, Manufacturing and Controls Information. February 2003. <http://www.fda.gov/cder/guidance/5427dft.pdf>
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Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Chemistry, Manufacturing, and Controls Documentation, October 1998.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
Bioequivalence of Endogenous Drugs