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Evaluation of the Proposed FDA Pilot Dose-response Methodology for Topical Corticosteroid Bioequivalence Testing

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REFERENCES

Letter

  1. Guidance: Topical dermatologic corticosteroids in vivo bioequivalence. Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, Rockville, MD. June 2, 1995.

  2. P. H. Demana, E. W. Smith, R. B. Walker, J. M. Haigh, and I. Kanfer. Pharm. Res. 14:303–307 (1997).

    Google Scholar 

  3. L. K. Pershing. Drug Info. J. 29:923–34 (1995).

    Google Scholar 

  4. N. H. G. Holford. Clin. Pharmacokinet. 6:429–53 (1981).

    Google Scholar 

  5. S. Dutta, Y. Matsumoto, and W. F. Ebling. J. Pharm Sci. 85:232–239 (1996).

    Google Scholar 

  6. V. P. Shah. C. C. Peck, and J. Skelly. Arch Dermatol. 125:1558–1561 (1989).

    Google Scholar 

  7. L. K. Pershing, L. D. Lambert, V. P. Shah, and S. Y. Lam. Int. J. Pharm. Sci. 86:201–210 (1992).

    Google Scholar 

  8. J. Ashworth. Acta Derm. Venereol. 151(Suppl.):20–25 (1989).

    Google Scholar 

  9. Interim guidance for topical corticosteroids: In vivo bioequivalence and in vitro release methods. Office of Generic Drugs, Food and Drug Administration, Rockville, MD. July 1, 1992.

Reply

  1. P. H. Demana, E. W. Smith, R. B. Walker, J. M. Haigh, and I. Kanfer. Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing. Pharm. Res., 14:303–307 (1997).

    Google Scholar 

  2. G. L. Coleman, I. Kanfer, and J. M. Haigh. Comparative blanching activities of proprietary diflucortolone valerate topical preparations. Dermatologica, 156:224–230 (1978).

    Google Scholar 

  3. J. M. Haigh, E. Meyer, E. W. Smith, and I. Kanfer. The human skin blanching assay for in vivo topical corticosteroid assessment. I. Reproducibility of the assay. Int. J. Pharm. 152:179–184 (1997).

    Google Scholar 

  4. S. Dutta, Y. Matsumoto, and W. F. Ebling. Is it possible to estimate the parameters of the sigmoid EMAX model with truncated data typical of clinical studies? J. Pharm. Sci., 85:232–239 (1996).

    Google Scholar 

  5. M. J. Waring, L. Monger, D. A. Hollingsbee, G. P. Martin, and C. Marriott. Assessment of corticosteroid-induced skin blanching—evaluation of the Minolta chromameter CR200. Int. J. Pharm., 94:211–222 (1993).

    Google Scholar 

  6. L. K. Pershing. Assessment of topical corticosteroid-induced skin blanching response using the visual McKenzie-Stoughton and Calorimetric methods. Drug. Inf. J., 29:923–934 (1995).

    Google Scholar 

  7. E. W. Smith, R. B. Walker, and J. M. Haigh. Analysis of chromameter results obtained from corticosteroid-induced skin blanching. I. Manipulation of data. Pharm. Res., (in press).

  8. L. Endrenyi, M. Gao, and Y. Hao. Exploratory and population pharmacodynamic analysis of pilot dose-response data in the bioequivalence testing of topical corticosteroid preparations. Drug Inf. J., 31: (in press).

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Authors and Affiliations

  1. Office of Pharmaceutical Science, CDER, US FDA, Rockville, Maryland

    Gur Jai Pal Singh, Nicholas Fleischer, Lawrence Lesko & Roger Williams

Authors
  1. Gur Jai Pal Singh
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  2. Nicholas Fleischer
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  3. Lawrence Lesko
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  4. Roger Williams
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Singh, G.J.P., Fleischer, N., Lesko, L. et al. Evaluation of the Proposed FDA Pilot Dose-response Methodology for Topical Corticosteroid Bioequivalence Testing. Pharm Res 15, 4–7 (1998). https://doi.org/10.1023/A:1011980115866

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  • DOI: https://doi.org/10.1023/A:1011980115866

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