Transdermal drug delivery system regulatory issues

Transdermal Drug Delivery, Second Edition: Revised and Expanded

Volumn , Issue , 2002, Pages 361-367

  Shah, Vinod P ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056982651     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (9)

1. VP Shah, JP Skelly. Regulatory considerations in transdermal drug delivery systems in the United States. In: YW Chien, ed. Transdermal Controlled Systemic Medications. New York: Marcel Dekker, 1987, pp 399-410.
2. VK Tammara, RK Baweja, A Dorantes, JP Hunt, FR Pelsor, H Sun, VP Shah, JK Wilkin. Biopharmaceutical considerations for topical and transdermal drug delivery systems. In: TP Ghosh, WR Pfister, SI Yum, eds. Transdermal and Topical Drug Delivery Systems. Buffalo Grove, IL, Interpharm Press, 1997, pp 629-658.
3. FDA Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products—general considerations. October 2000.
4. VP Shah, SV Dighe, YC Huang, F Fang, DB Hare, LJ Lesko, RL Williams. New and generic transdermal nitroglycerin systems: regulatory considerations. Eur J Pharm Biopharm 41:189-193, 1995.
5. VP Shah, NW Tymes, L Yamamoto, JP Skelly. In vitro dissolution profile of transdermal nitroglycerin patches using paddle method. Int J Pharm 32: 243-250, 1986.
6. VP Shah, LJ Lesko, RL Williams. In vitro evaluation of transdermal drug delivery. Eur J Pharm Biopharm 41:163-167, 1995.
7. Transdermal drug delivery systems—general drug release standards. USP 23/NF 18, Apparatus 5, pp 1796-1797.
8. VP Shah, CC Peck, RL Williams. Skin penetration enhancement—clinical pharmacological and regulatory considerations. In: KA Walters, J Hadgraft, eds. Pharmaceutical Skin Penetration Enhancement. New York: Marcel Dek-ker, 1993, pp 417-427.
9. GA Van Buskirk et al. Scale-up of adhesive transdermal drug delivery systems. Pharm Res 14:848-852, 1997.