Lists of NTIDs [Regulatives / Guidelines]
Hi all,
Can anybody tell if I am doing study for canada and the drug is NTI and the acceptance limit is 80-125 for cmax and 90-112 for AUC then what upper/lower equivalence bound I have to consider for sample size calculation.
Can anybody tell if I am doing study for canada and the drug is NTI and the acceptance limit is 80-125 for cmax and 90-112 for AUC then what upper/lower equivalence bound I have to consider for sample size calculation.
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Kumar Naidu
Kumar Naidu
Complete thread:
- CI for Narrow Therapeutic Index Drugs Ken Peh 2013-08-01 19:21
- CI for Narrow Therapeutic Index Drugs jag009 2013-08-01 20:06
- Lists of NTIDs Helmut 2013-08-02 02:59
- Lists of NTIDskumarnaidu 2013-09-24 11:56
- Acceptance ranges in sample size estimation Helmut 2013-09-24 13:26
- Lists of NTIDs Dr_Dan 2013-09-24 14:30
- Lists of NTIDs kvgreddy06 2013-10-17 12:29
- Lists of NTIDs Dr_Dan 2013-10-17 14:29
- Lists of NTIDs kvgreddy06 2013-10-17 12:29
- Lists of NTIDskumarnaidu 2013-09-24 11:56
