These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
3. Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing. Demana PH; Smith EW; Walker RB; Haigh JM; Kanfer I Pharm Res; 1997 Mar; 14(3):303-8. PubMed ID: 9098871 [TBL] [Abstract][Full Text] [Related]
4. The vasoconstrictor assay in bioequivalence testing: practical concerns and recent developments. Stoughton RB Int J Dermatol; 1992 Oct; 31 Suppl 1():26-8. PubMed ID: 1428464 [TBL] [Abstract][Full Text] [Related]
5. Bioequivalence of topical generic products. Part 2. Paving the way to a tailored regulatory system. Miranda M; Sousa JJ; Veiga F; Cardoso C; Vitorino C Eur J Pharm Sci; 2018 Sep; 122():264-272. PubMed ID: 29981406 [TBL] [Abstract][Full Text] [Related]
6. Human test models for bioequivalence of topical corticosteroids: a review. Olsen EA Int J Dermatol; 1992 Oct; 31 Suppl 1():9-13. PubMed ID: 1428469 [TBL] [Abstract][Full Text] [Related]
7. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Olsen EA Arch Dermatol; 1991 Feb; 127(2):197-201. PubMed ID: 1990984 [TBL] [Abstract][Full Text] [Related]
8. Evaluation of in vivo bioequivalence methodology for topical clobetasol 17-propionate based on pharmacodynamic modeling using Chinese skin. Tsai JC; Cheng CL; Tsai YF; Sheu HM; Chou CH J Pharm Sci; 2004 Jan; 93(1):207-17. PubMed ID: 14648650 [TBL] [Abstract][Full Text] [Related]
9. Bioequivalence of metered-dose inhaled medications. Wong BJ; Hargreave FE J Allergy Clin Immunol; 1993 Sep; 92(3):373-9. PubMed ID: 8360387 [No Abstract] [Full Text] [Related]
10. Regulatory Approaches and Considerations in Establishing Bioequivalence of Inhaled Compounds. Mayers I; Bhutani M J Aerosol Med Pulm Drug Deliv; 2018 Feb; 31(1):18-24. PubMed ID: 28708443 [TBL] [Abstract][Full Text] [Related]
11. Progress in methodologies for evaluating bioequivalence of topical formulations. Shah VP Am J Clin Dermatol; 2001; 2(5):275-80. PubMed ID: 11721645 [TBL] [Abstract][Full Text] [Related]
12. A generic drug primer: regulatory aspects and scientific concepts. Henderson JD; White GL Mil Med; 1998 Apr; 163(4):193-7. PubMed ID: 9575760 [TBL] [Abstract][Full Text] [Related]
13. Generic topical corticosteroids. Med Lett Drugs Ther; 1988 May; 30(765):49-50. PubMed ID: 3362092 [No Abstract] [Full Text] [Related]
15. Clinical trials of topical corticosteroids in psoriasis: correlations with the vasoconstrictor assay. Cornell RC Int J Dermatol; 1992 Oct; 31 Suppl 1():38-40. PubMed ID: 1428467 [TBL] [Abstract][Full Text] [Related]
16. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products. Braddy AC; Davit BM; Stier EM; Conner DP AAPS J; 2015 Jan; 17(1):121-33. PubMed ID: 25344440 [TBL] [Abstract][Full Text] [Related]
17. Revisiting FDA's 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations. Ozdin D; Sharma N; Lujan-Zilbermann J; Colucci P; Kanfer I; Ducharme MP J Pharm Pharm Sci; 2018; 21(1):413-428. PubMed ID: 30407906 [TBL] [Abstract][Full Text] [Related]
18. Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs. Li Z; Fang L; Jiang W; Kim MJ; Zhao L Curr Neurol Neurosci Rep; 2017 Sep; 17(11):82. PubMed ID: 28929357 [TBL] [Abstract][Full Text] [Related]
19. Bioequivalence of topical generic products. Part 1: Where are we now? Miranda M; Sousa JJ; Veiga F; Cardoso C; Vitorino C Eur J Pharm Sci; 2018 Oct; 123():260-267. PubMed ID: 30053463 [TBL] [Abstract][Full Text] [Related]
20. Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling. Singh GJ; Adams WP; Lesko LJ; Shah VP; Molzon JA; Williams RL; Pershing LK Clin Pharmacol Ther; 1999 Oct; 66(4):346-57. PubMed ID: 10546918 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]