The human skin-blanching assay for comparing topical corticosteroid availability
- Smith, Eric W, Meyer, Eric, Haigh, John M, Maibach, Harold I
- Authors: Smith, Eric W , Meyer, Eric , Haigh, John M , Maibach, Harold I
- Date: 1991
- Language: English
- Type: Article
- Identifier: vital:6433 , http://hdl.handle.net/10962/d1006604
- Description: The human skin blanching assay remains in widespread use as a reliable, qualitative, comparative indicator of topical corticosteroid availability and potency. The experimental refinements promulgated by certain researchers in this field have yielded a versatile bioassay for the accurate assessment of new drugs or delivery vehicles. With the increasing appearance of generic topical corticosteroid formulations which compete with trade-name equivalents, the vital importance of this assay in regulatory affairs and assessing bioequivalence has been re-emphasized. It is stressed that if the blanching assay is to be used in this sphere, then multiple-reading trials must be conducted; important registration or clinical decisions cannot be made with any validity from short-term assessments.
- Full Text:
- Date Issued: 1991
- Authors: Smith, Eric W , Meyer, Eric , Haigh, John M , Maibach, Harold I
- Date: 1991
- Language: English
- Type: Article
- Identifier: vital:6433 , http://hdl.handle.net/10962/d1006604
- Description: The human skin blanching assay remains in widespread use as a reliable, qualitative, comparative indicator of topical corticosteroid availability and potency. The experimental refinements promulgated by certain researchers in this field have yielded a versatile bioassay for the accurate assessment of new drugs or delivery vehicles. With the increasing appearance of generic topical corticosteroid formulations which compete with trade-name equivalents, the vital importance of this assay in regulatory affairs and assessing bioequivalence has been re-emphasized. It is stressed that if the blanching assay is to be used in this sphere, then multiple-reading trials must be conducted; important registration or clinical decisions cannot be made with any validity from short-term assessments.
- Full Text:
- Date Issued: 1991
Topical corticosteroid-induced skin blanching measurement, eye or instrument?
- Haigh, John M, Smith, Eric W
- Authors: Haigh, John M , Smith, Eric W
- Date: 1991
- Language: English
- Type: Article
- Identifier: vital:6378 , http://hdl.handle.net/10962/d1006296
- Description: We have read with interest a recent critique of the human skin blanching assay. We are concerned about the accuracy of statements and the interpretation of results presented in this publication. Having successfully employed this bioassay for over 15 years, and having noted similar, productive usage of this optimized technique reported from laboratories worldwide, the negativism expressed in the critique could dissuade potential researchers from employing this extremely useful assay procedure.
- Full Text:
- Date Issued: 1991
- Authors: Haigh, John M , Smith, Eric W
- Date: 1991
- Language: English
- Type: Article
- Identifier: vital:6378 , http://hdl.handle.net/10962/d1006296
- Description: We have read with interest a recent critique of the human skin blanching assay. We are concerned about the accuracy of statements and the interpretation of results presented in this publication. Having successfully employed this bioassay for over 15 years, and having noted similar, productive usage of this optimized technique reported from laboratories worldwide, the negativism expressed in the critique could dissuade potential researchers from employing this extremely useful assay procedure.
- Full Text:
- Date Issued: 1991
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