Current and future Statistical Consideration in Bioequivalence TrialsCurrent and future Statistical Consideration in Bioequivalence Trials
- Authors
- Park, Sang-Gue
- Issue Date
- Nov-2006
- Publisher
- 한국데이터정보과학회
- Keywords
- Bioequivalence; Crossover design; Population and Individual BE; Prescribability and Switchability
- Citation
- 한국데이터정보과학회 추계논문 발표회, pp 43 - 48
- Pages
- 6
- Journal Title
- 한국데이터정보과학회 추계논문 발표회
- Start Page
- 43
- End Page
- 48
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61043
- 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- In 2001 US FDA proposed a draft guidance for future in vivo bioequivalence studies.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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