Bioequivalence and Bioavailability Forum • Sample Size Based on Pharmacodynamic endpoints

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

posted by sury – India, 2019-04-05 08:36 (1840 d 20:27 ago) – Posting: # 20122
Views: 3,720

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]

Complete thread:

Sample Size Based on Pharmacodynamic endpoints sury 2019-04-03 12:28
- Sample Size Based on Pharmacodynamic endpoints ElMaestro 2019-04-03 13:22
  - Sample Size Based on Pharmacodynamic endpoints nobody 2019-04-03 13:36
  - Sample Size Based on Pharmacodynamic endpointssury 2019-04-05 06:36
    - Sample Size Based on Pharmacodynamic endpoints ElMaestro 2019-04-05 08:22
      - Sample Size Based on Pharmacodynamic endpoints nobody 2019-04-05 08:37