For review and approval of drug products, a 95% confidence interval approach for evaluation of new drugs is commonly used, while a 90% confidence interval approach is considered for assessment of generic drugs and biosimilar products. In the past decade, FDA has been challenged for adopting different standards (i.e., 5% type-I error rate for new drugs and 10% type-I error rate for generics/biosimilars) for regulatory submissions of drugs and biologics. This note intends to clarify the confusion by pointing out the fundamental differences between (i) the concepts of point hypotheses and interval hypotheses, and (ii) the concepts of interval hypotheses testing and confidence interval approach. In general, the method of interval hypotheses testing is not equivalent to the confidence interval approach although they may be operationally equivalent under certain conditions.

对于药品的审查和批准，通常使用95％置信区间方法评估新药，而90％置信区间方法被认为评估仿制药和生物仿制药。在过去的十年中，FDA因采用不同的标准（即新药的I型错误率5％，仿制药/生物仿制药的I型错误率10％）而面临挑战。本说明旨在通过指出（i）点假设和区间假设的概念以及（ii）区间假设检验和置信区间方法的概念之间的根本区别来澄清混淆。一般来说，