BE study designing related doubts [Design Issues]

posted by gsrao2022 – India, 2021-03-28 20:12 (300 d 02:19 ago) – Posting: # 22295
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I have some doubts, could anyone help me out

  1. If any molecule intra subject CV of Cmax is less than 30 and for AUC more than 30. in this case can we go for replicate design for EU regulatory?

  2. For replicate study design which should be preferred partial replicate or full replicate? which is preferred by regulatory?

  3. What is the maximum half life to go for Parallel study?

  4. What is the minimum days of wash out period required (in days) for eg. if a molecule half-life is 1 hour?

  5. If a study passes 90 % CI, but the power is below 80 does regulatory approves the study?



Edit: Category changed; see also this post #1. Please follow the Forum’s Policy[Helmut]

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