Narrow therapeutic index drug [RSABE / ABEL]

posted by Mahesh M – India, 2014-01-02 11:32 (4149 d 22:46 ago) – Posting: # 12124
Views: 6,614

Hello all,

My query is regarding the narrow therapeutic index drugs
  1. To demonstrate BE study on narrow therapeutic index drug: Two treatment, four period fully replicated design is more appropriate? (US FDA).
  2. 90 % CI should be 90-111.11 %?
Eg. Draft guidance of Tacrolimus clearly mention about design and bioequivalence criteria but what’s about other NTI drugs like Sirolimus, Everolimus etc.

Kindly suggest
Regards
Mahesh

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