自助法及随机加权法在生物等效性评价中应用.pdf

(bioequivalence, BE) (average bioequivalence, ABE), (population bioequivalence, PBE), (individual bioequivalence, IBE). (FDA) 1997 FDA PBE IBE PBE IBE ÆÆ PBE IBE ABE, PBE IBE Æ IBE FDA PBE Æ PBE IBE, IBE I Abstract The purpose of study bioequivalence(BE) is to show that two formulations produce similar bioavailabilities. In general the BE includes average bioequiva- lence(ABE), population bioequivalence(PBE) and individual bioequivalence (IBE). The US Food and Drug Administration (FDA) proposed a draft guidance for the pharmaceutical industry in 1997. FDA prefer to study PBE and IBE than ABE with the more research on PBE and IBE. At present , the literature on PBE and IBE are not abundant. These literature almost all concentrate on the parametric methods except some on bootstrap method . We attempt to use bootstrap and random weighting method to assess PBE and IBE. In chapter 1, we introduce the progress and significance to assess BE . In chapter 2, the bootstrap method and the random weighting method are presentated. In chapter 3, we give detailed description on ABE, PBE and IBE. We emphasize the bootstrap method on assessing IBE in present literature and the parametric method in assessing PBE in FDA. Chapter 4 includes our main research work on PBE and IBE, we apply the bootstrap method and the random weighting method to evaluate PBE and IBE and improve the process of FDA . The power of random weighting method is the most excellent . Key words: bioequivalence , average bioequivalence, population bioequivalence, i