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Application of the Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroid in yellow‐skinned Japanese population: Validation study using a chromameter
Author(s) -
KEIDA Tomoko,
HAYASHI Nobukazu,
KAWASHIMA Makoto
Publication year - 2006
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/j.1346-8138.2006.00159.x
Subject(s) - bioequivalence , food and drug administration , medicine , drug , pharmacology , corticosteroid , drug administration , dermatology , pharmacokinetics
The American Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroids in 1995 (the Guidance) requires measurement of the skin blanching response with a chromameter for evaluation of cutaneously applied corticosteroid formulations. The Japanese government decided to apply the same guidelines in 2003, despite there having been no reported trial for the yellow‐skinned races. The purpose of this study was to obtain basic data of corticosteroid‐induced skin blanching response measured with a chromameter on yellow‐skinned races. Four studies were performed according to the Japanese version of the Guidance for Industry using a chromameter on the forearms of healthy Japanese volunteers. This involved: (i) a validation study of proper duration of treatment exposure (dose duration); (ii) a comparison study of two dermatological corticosteroid products that represented different potency classes; (iii) inspection of reproducibility using right and left forearms; and (iv) study of seasonal difference. We showed that: (i) the same medication can give different values of ED 50 (the dose duration required to achieve 50% of the fitted areas under the effect curves [AUEC] max value) under different dose durations; (ii) ED 50 do not always represent the potency of the corticosteroid; (iii) the results of AUEC at maximum duration were similar, but AUEC at an approximate ED 50 duration time varied widely; and (iv) the results of AUEC were different according to season. In conclusion the dose duration relationships, determination of the AUEC max , and the ED 50 could be obtained on yellow‐skinned races using the FDA method. However, negligible differences were found in our study regarding dose duration, reproducibility and seasonal change.