Analysis of chromameter results obtained from corticosteroid-induced skin blanching. I. Manipulation of data
- Authors: Smith, Eric W , Haigh, John M , Walker, Roderick B
- Date: 1998
- Language: English
- Type: text , Article
- Identifier: vital:6424 , http://hdl.handle.net/10962/d1006559
- Description: Purpose. One of the unresolved issues in the FDA Guidance document for topical corticosteroid bioequivalence testing is the method of manipulation suggested for the chromameter data. The purpose of this study was to manipulate the instrumental data from a typical blanching study in a number of ways to investigate the appropriateness of these procedures for comparison with the subjective visually-assessed results. Methods. The human skin blanching assay methodology routinely practiced in our laboratories was utilised and the vasoconstriction produced by two corticosteroid formulations of different potency was assessed visually and instrumentally by use of a Minolta chromameter. The instrumental data were corrected for zero-time and unmedicated site readings. In addition, Euclidean distances were calculated using all data generated by the instrument. Results. Individually the a-, b- and L-scale chromameter values are imprecise and there is negligible vasoconstriction response recorded for the moderately potent formulation. Arithmetical manipulation of the data as suggested by the FDA does not appear to improve the quality of the data in any way. Euclidean distance analysis more closely resembles the visual data and appears to have better precision. Conclusions. It is clear that mathematical correction of chromameter data is unnecessary, especially since the instrumental data are extremely imprecise. Furthermore, the assessment of each individual chromameter index does not adequately characterise the blanching response profile. It is therefore suggested that Euclidean distance may be a better measure on which to base an analysis of bioequivalence than the truncated data set methodology currently suggested by the FDA.
- Full Text: false
- Date Issued: 1998
Can shed snakeskin be considered to be a model membrane for human stratum corneum?
- Authors: Haigh, John M , Beyssac, E , Aiache, J M
- Date: 1998
- Language: English
- Type: Article
- Identifier: vital:6383 , http://hdl.handle.net/10962/d1006303
- Description: Recently there has been some interest in the use of shed snake skin as a "model" membrane for in vitro diffusion studies. Many different species of snake have been utilised as well as different skin sites (dorsal and ventral). The species is usually named and sometimes the skin site is indicated butsometimes neither species nor skin site is reported. Insome countries it is particularly difficult to obtain human skin for in vitro experimentation and it is therefore important to have alternate biological or synthetic membranes which mimic human skin membranes for diffusion experiments. In South Africa. shed snake skin is easily obtainable from the many snake parks present in the country. Since snakes moult periodically, a single animal can provide repeated sheds, thus reducing interindividual variability. Skins can be obtained without injury to the animal and do not have to be subjected to chemical or heat stress prior to use. The epidermis is shed as a large intact sheet, thus a single snake skin can provide multiple samples. Shed snake skin is not a living tissue, can be stored for long periods at room temperature and is easily transported. Stored and fresh snake skins appear to show no differences in permeability. Since snake skin lacks hair follicles,the problems associated with the transfollicular route of penetration, which may be significant in mammalian skins, can be avoided.
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- Date Issued: 1998
Evaluation of the proposed FDA pilot-dose response methodology for topical corticosteroid bioeqivalence testing [authors' reply in Letters to the Editor]
- Authors: Smith, Eric W , Walker, Roderick B , Haigh, John M , Kanfer, Isadore
- Date: 1998
- Language: English
- Type: text , Article
- Identifier: vital:6423 , http://hdl.handle.net/10962/d1006558
- Description: Reply to: Letter to the Editor by Singh GJ; Fleischer N; Lesko L; Williams R - relating to original article in Pharmaceutical Research (USA), Mar 1997, vol. 14, pp. 303-308.
- Full Text: false
- Date Issued: 1998
In vitro permeation of progesterone from a gel through the shed skin of three different snake species
- Authors: Haigh, John M , Beyssac, E , Chanet, L , Aiache, J M
- Date: 1998
- Language: English
- Type: Article
- Identifier: vital:6366 , http://hdl.handle.net/10962/d1006066
- Description: The in vitro diffusion of progesterone from a gel formulation using the European Pharmacopoeia method for transdermal dosage forms is described. The membranes used were the dorsal and ventral portions of the shed skin of three different species of snake. Considerable differences are apparent between the dorsal and ventral sites and between the different species of snake. The dorsal area shows better permeability for progesterone and the permeability order for the different species is python>cobra>viper. These differences may be due to the thickness of the skin and the hinge:scale ratio. The results indicate that shed snake skin is not a model membrane for human skin.
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- Date Issued: 1998
New developments in the methodology available for the assessment of topical corticosteroid-induced skin blanching
- Authors: Haigh, John M , Smith, Eric W , Maibach, Howard I
- Date: 1998
- Language: English
- Type: text , Article
- Identifier: vital:6384 , http://hdl.handle.net/10962/d1006305
- Description: Since the publication of the previous edition of this book there have been considerable developments and controversy in the field of topical corticosteroid bioequivalence assessment. There has been considerable discussion in the literature concerning the use of the Minolta chromameter for the measurement of corticosteroid-induced skin blanching, as it is believed this instrument would produce more objective results than the visual grading procedure. These efforts culminated in the release of a guidance document from the Food and Drug Administration (FDA) detailing the procedures to be followed for the determination of topical corticosteroid bioequivalence using the chromameter. Since the promulgation of this document there have been challenges on the validity and scientific merit of the documented procedures, and recently the FDA itself conceded that it may be necessary to redefine some of the protocol evaluations. This chapter attempts to redefine the current standing of the two methods of response assessment.
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- Date Issued: 1998
The requirements for accurate analysis of pharmaceutical research at South African Universities
- Authors: Haigh, John M , Smith, Eric W
- Date: 1998
- Language: English
- Type: text , Article
- Identifier: vital:6367 , http://hdl.handle.net/10962/d1006067
- Description: International Pharmaceutical Abstracts is a valuable database for pharmaceutical research, although the multisiciplinary nature of this field implies that the database should only be the starting point of a search. This database is totally inappropriate for comparing outputs of individual pharmacy teaching institutions.
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- Date Issued: 1998