IV-IVC for topically applied preparations - A critical evaluation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 60, Issue 2, 2005, Pages 309-314

  Shah, Vinod P ^a  

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

Author keywords

Dermatopharmacokinetics; DPK; In vitro release; In vitro in vivo correlation; Pharmacodynamics; Rheological properties; Spreadability

Indexed keywords

CLOBETASOL PROPIONATE; GENERIC DRUG; RETINOIC ACID;

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG ACTIVITY; DRUG FORMULATION; DRUG RELEASE; FLOW KINETICS; IN VITRO STUDY; IN VIVO STUDY; SKIN PENETRATION; SKIN PERMEABILITY;

ADMINISTRATION, TOPICAL; HUMANS; PHARMACOKINETICS; SKIN; SOLUBILITY; VISCOSITY;

EID: 20444408792     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2004.09.015     Document Type: Conference Paper

References (12)

1. V.P. Shah, G.L. Flynn, A. Yacobi, H.I. Maibach, C. Bon, N.M. Fleischer, T.J. Franz, S.A. Kaplan, J. Kawamoto, L.J. Lesko, J.-P. Marty, L.K. Pershing, H. Schaefer, J.A. Sequeira, S.P. Shrivatsava, J. Wilkin, and R.L. Williams AAPS/FDA workshop report: bioequivalence of topical dermatological dosage forms - methods of evaluation of bioequivalence Pharm. Res. 15 1998 167 171
2. L.K. Pershing, J.L. Nelson, J.L. Corelett, S.P. Shrivastava, D.B. Hare, and V.P. Shah Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products J. Am. Acad. Dermatol. 48 2003 740 751
3. Guidance: topical dermatologic corticosteroids: in vivo bioequivalence, Office of Generic Drugs, Center for Drug Evaluations and Research, FDA, June 1995.
4. V.P. Shah, J.S. Elkins, and R.L. Williams Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products Pharm. Dev. Technol. 4 1999 377 385
5. R. Pillai, V. Shah, L. Abriola, P. Caetano, and G.L. Flynn Release of hydrocortisone from a cream matrix: dependency of release on suspension concentration and measurement of solubility and diffusivity Pharm. Dev. Technol. 6 2001 373 384
6. G.L. Flynn, V.P. Shah, S.N. Tenjarala, M. Corbo, D. DeMagistris, T.G. Feldman, T.J. Franz, D.R. Miran, D.M. Pearce, J.A. Sequeira, J. Swarbrick, J.C.T. Wang, A. Yacobi, and J.L. Zatz Workshop report: assessment of value and applications of in vitro testing of topical dermatological drug products Pharm. Res. 16 1999 1325 1330
7. CDER, FDAGuidance: SUPAC-SS Nonsterile semisolid dosage forms, Scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation, May 1997.
8. H.J. Weigmann, J. Lademann, S. Schanzer, U. Lindemann, R. von Pelchrzim, H. Schaefer, W. Sterry, and V. Shah Correlation of the local distribution of topically applied substances inside the stratum corneum determined by tape-stripping to differences in bioavailability Skin Pharmacol. Appl. Skin Physiol. 14 Suppl. 1 2001 98 102
9. V.P. Shah, J. Elkins, and J.P. Skelly Relationship between in vivo skin blanching and in vitro release for betamethasone valerate creams J Pharm. Sci. 81 1992 104 106
10. D. Caron, C. Queille-Roussel, V.P. Shah, and H. Schaefer Correlation between drug penetration and blanching effect of topically applied hydrocortisone cream in human beings J. Am. Acad. Dermatol. 23 1990 454 462
11. FDA Advisory committee for Pharmaceutical Science, Transcript of discussion, November 2001.
12. H.J. Weigmann, J. Lademann, R. von Pelchrizm, W. Sterry, T. Hagemeister, R. Molzahn, M. Schaefer, M. Lindsxheid, H. Schaefer, and V.P. Shah Bioavailability of clobetasol propionate - quantification of drug concentrations in the stratum corneum by dermatopharmacokinetics using tape stripping Skin Pharmacol. Appl. Skin Physiol. 12 1999 46 53