Bioequivalence studies of topical preparations: statistical considerations.
To 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 products.
Hauck
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Department of Epidemiology and Biostatistics, University of California, School of Medicine, San Francisco 94143-0560.
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000493:pharmacokinetics*; D005938:Glucocorticoids; D006801:Humans; D012107:Research Design; D013223:Statistics as Topic; D013810:Therapeutic Equivalency
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids