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[生物书合集].Advances.in.Clinical.TBiostatisti

[生物书合集].Advances.in.Clinical.TBiostatisti

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PNU Trial The incorporation of patient-specific covariate information into a Baye- sian design scheme will be exemplified through a phase I study of PNU- 214565 (PNU) involving patients with advanced adenocarcinomas of gastrointestinal origin (Babb and Rogatko, 2001). Previous clinical and preclinical studies demonstrated that the action of PNU is moderated by the neutralizing capacity of anti-SEA antibodies. Based on this, the MTD of PNU was defined as a function of the pretreatment concentration of circulating anti-SEA antibodies. Specifically, the MTD was defined as the dose level expected to induce DLT in a proportion u = .1 of the patients with a given pretreatment anti-SEA concentration. 2. GENERAL BAYESIAN METHODOLOGY
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