한국데이터정보과학회:학술대회논문집
- 2006.11a
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- Pages.43-48
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- 2006
Current and future Statistical Consideration in Bioequivalence Trials
Abstract
In 2001 US FDA proposed a draft guidance for future in vivo bioequivalence studies. The guidance suggested specific criteria for new drug sponsors to show prescribability and switchability in bioequivalence testing for approval of generic drugs. However, there is less acceptance of the need to change statistical procedures and study designs from those currently used to assess the current criterion of average bioequivalence. The measures of population and individual bioequivalence testing are introduced and statistical procedures for them are discussed.
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