ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03514.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractTo be approved for marketing, a potential generic pharmaceutical product must demonstrate bioequivalence, that is, a rate and extent of absorption similar to those of the currently marketed (“innovator”) product. For oral products, design and statistical analysis for studies conducted to determine whether two products are bioequivalent have become reasonably standardized; the design is crossover, and analysis is based on the two one‐sided tests principle. The purpose of this overview is to consider whether the practices for oral products apply to topical products, and where different procedures may be required. The principles behind the practices for oral products are seen, largely, to carry over to topical pro

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb04010.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractThree biopsies of normal skin and 15 biopsies collected from patients with psoriasis vulgaris were analyzed for the expression of the 50 kd cytokeratin using direct immunofluorescence and ABC technique before and after local treatment with anthralin 0.1% in a petroiatum base, with 0.05% betamethasone dipropionate cream, and finally, after PUVA treatment. Antiserum against the 50 kd anticytokeratin reacted with tissue sections of normal skin, staining cells in the basal layer, while the psoriatic skin sections before the various treatments showed a staining concerning the whole thickness of the epidermis. After the various therapies, the 50 kd cytokeratin immunoreactivity was observed only in the basal layer of those psoriatic skin sections that showed complete clinical clearing, while it was observed in the whole thickness of psoriatic patches that did not clear. These data suggest that the normalization of the 50 kd cytokeratin expression pattern can be considered as a marker of clinical remission of psoriasis.

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03516.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractPemphigus lesions appeared in a 58‐year‐old man who was talking captopril for his hypertension. Drug withdrawal resulted in complete remission of the eruption. The subsequent use of enalapril as an antihypertensive agent caused a recurrence of pemphigus lesions along with onset of itching and dermographism. Intercellular antibodies were not found. Discontinuance of enalapril therapy had no effect on the clinical course. Steroid treatment was needed to resolve the eruption. Recently repeated immunofluorescent studies disclosed intercellular IgG antibodies in the serum at a low titer. Pemphigus induction could be initially related to the thiol acantholytic property of captopril. Subsequent production of intercellular antibodies and drug‐activation of the kinin system could be responsible for rela

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03517.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractA simple procedure is developed, which can be used as a quality control test. The method utilizes commercially available diffusion cell assembly, synthetic membrane, and an appropriate receptor phase. The amount of drug released over time is determined using an HPLC method. From this, the drug release rate, flux, μg/cm2/min0.5is calculated. This drug release rate can serve as a good quality control test to assure batch‐to‐batch unifor

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb04011.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractPatients with bullous pemphigoid and epidermolysis bullosa acquisita may have similar clinical, histologic, and routine immunohistologic features. These two diseases can be distinguished by routine diagnostic studies either on a patient's serum tested by indirect immunofluorescence on salt‐split normal skin or by obtaining a fresh perilesional skin biopsy, inducing a split at the lamina lucida, and testing for the site of IgG deposition by direct immunofluorescence. Often the serum studies are negative, while direct immunofluorescent studies yield the characteristic linear IgG staining of the basement membrane zone. To eliminate the need for a repeat biopsy to make a laboratory differential diagnosis, we studied the efficacy of salt‐splitting perilesional skin biopsies that had been previously submitted and frozen for routine direct immunofluorescent studies. The biopsies were thawed, salt‐split, and processed for direct immunofluorescence. Three epidermolysis bullosa acquisita biopsies and seven bullous pemphigoid biopsies examined demonstrated IgG staining at sites consistent with their respective diagnoses. The IgG appeared in the dermal side of the split biopsies in epidermolysis bullosa acquisita and predominantly, or exclusively, in the epidermal side in bullous pemphigoid. Thus the direct immunofluorescent study of previously frozen and subsequently salt‐split skin biopsies may be used for the differential diagnosis of bullous pemphigoid from epidermolysis bullosa acquisita. In most cases, it may eliminate the need for a repeat

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03518.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractIt would be desirable to develop an alternative system to clinical studies to evaluate the potency of generic topical corticosteroids and of new formulations of existing innovator corticosteroids. The vasoconstrictor assay is a reliable method for testing potency; however, its results do not always agree with clinical studies. Psoriasis offers an ideal clinical model to evaluate corticoid potency because the ability to perform within‐patient comparisons of the treatment of bilateral lesions permits meaningful comparisons with a relatively small sample size. The results of bilateral comparisons in psoriasis agreed with those of the vasoconstrictor assay in 20 of 23 comparisons of active agents and in numerous comparisons of active corticosteroids with a placebo. Eczematous dermatoses do not lend themselves well to bilateral paired comparison studies and therefore require parallel treatment studies with relatively large sample sizes to produce statistically significant comparison

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb04012.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb04013.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractThe characteristics of three primary bullous diseases, pemphigus, pemphigoid, and dermatitis herpetiformis, seen in this country, probably reflecting this region, are discussed and compared to those reported in the literature in the West. One hundred and forty‐eight patients with bullous diseases were seen over a period of 15 years. The criteria for confirmation of clinical diagnosis were the findings of the direct immunofluorescent test. Pemphigus vulgaris was the commonest bullous disease. The incidence of bullous pemphigoid was highest in the Indians of Malaysian origin, and they are also more likely to develop pemphigus vulgaris than any other ethnic group. Linear IgA type formed the entire group of dermatitis herpetiformis. The granular type was not seen at all. The patients were treated with prednisolone alone or together with methotrexate or aza‐thioprine. Dapsone alone controlled the dermatitis herpetiformis. The known association between pemphigus and other diseases with immunologic disturbances was not found in this study. The natural history of the bullous disease as seen in the followup patients is described. Deaths in pemphigus and pemphigoid were more due to either complications of steroid therapy or unassociated diseases than the primary disease itself. Introduction of immunofluorescence as a diagnostic tool in pemphigus’ and extension of this facility to other bullous diseases has led to detailed characterization of these diseases as seen in the West; however, publications in English dealing with epidemiologic aspects of bullous diseases in this region are rare. The three primary bullous diseases, pemphigus vulgaris, bul‐lous pemphigoid, and dermatitis herpetiformis (DH), as seen in Malaysia, probably reflecting the pattern of disease in this region, will be discussed and features peculiar to this region will be high

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03519.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY

摘要:

AbstractPemphigus vulgaris developed in a 59‐year‐old man following a cutaneous thermal burn. This is an example of induced pemphigus and should be included with the small number of cases where this sequence has been repor

ISSN:0011-9059    

DOI:10.1111/j.1365-4362.1992.tb03520.x

出版商:Blackwell Publishing Ltd    

年代:1992

数据来源: WILEY