Sample Size Based on Pharmacodynamic endpoints [Power / Sample Size]

posted by sury – India, 2019-04-05 06:36  – Posting: # 20122
Views: 693

Thanks for your reply.....but i have few more doubts on this

Can we use the pharmacokinetic parameter ISCV for the sample size estimation for the clinical endpoint bioequivalence study?
is it will be in accordance with the regulatory requirement?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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