Providing evidence of efficacy for a new
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Stephen Ruberg; Victoria Cairns
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Article
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1998
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John Wiley and Sons
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English
โ 93 KB
๐ 1 views
There are many issues to consider when designing an efficacy package for drug registration. Generally in Europe and the United States, two or more confirmatory trials demonstrating efficacy (p(0)025, one-tailed) of the test treatment versus a suitable control group must be conducted with a priori de