Abstract:
:We address the issue of analysis of clinical data generated by the bridging study conducted in the new region to evaluate the similarity for extrapolation of the foreign clinical data. A bridging study is usually conducted in the new region only after the test product is approved for commercial marketing in the original region due to its proven efficacy and safety. Sufficient information on efficacy, safety, dosage, and dose regimen has already generated in the original region. The empirical Bayesian approach is proposed to synthesize the data generated by the bridging study and foreign clinical data generated in the original region for assessment of similarity between the new and the original regions. A method for sample size determination for the bridging study is also suggested. It can be shown that the total sample size is inversely proportional to the strength of the evidence for the efficacy presented in the original region and the proportion of the patients assigned to receive the test product in the bridging study.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Liu JP,Hsiao CF,Hsueh Hdoi
10.1081/bip-120014568keywords:
subject
Has Abstractpub_date
2002-08-01 00:00:00pages
401-8issue
3eissn
1054-3406issn
1520-5711journal_volume
12pub_type
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