1、从医学统计学看大型临床试验的概念理解 Guidance on Statistical Principles for Clinical Trialshttp:/www.fda.gov/ cber/publications.htmhttp:/www.nihs.go.jp/dig/ich/EUFDAMHWICH E9引用须知 Federal register Vol.63,49583 4 This guidance represents the agencys current thinking on statistical principles for clinical trials of drug
2、s and biologics. Page 49584 It does not create or confer any rights for, or on, any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute,regulations, or both.trials of drugs and biologics. Pag
3、e 49584 It does not create or confer any rights for, or on, any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute,regulations, or both.ICH E9引用须知 Federal register Vol.63,49583 4 该 指导 代表 FDA关于药品和生物制品临床试验统计学原则的当前认识。 它不产生任何权力，也不授予任何权力，既不为了任何人，也不针对任何人 , 它并不对 FDA或公众进行束缚。 如果有另外的方法符合应用法规和管理要求或二者兼俱，则那些方法尽可使用。
