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RegisterNTIDs [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2022-01-29 13:19 (308 d 17:21 ago) – Posting: # 22760
Views: 674
Hi Najib,
The Draft Guidance on Warfarin Sodium of 2012 was the first describing the FDA’s method of reference-scaling for NTIDs. All later ones refer to the first and state
For the sample size estimation see there (including examples and references).
❝ […] one PSG asks you to refer to the second, …
The Draft Guidance on Warfarin Sodium of 2012 was the first describing the FDA’s method of reference-scaling for NTIDs. All later ones refer to the first and state
For details about the Method for Statistical Analysis Using the Reference-Scaled Average Bioequivalence Approach for narrow therapeutic index drugs, refer to the Guidance on Warfarin Sodium Tablets.
For the sample size estimation see there (including examples and references).
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 19:37 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Helmut 2022-01-28 21:06
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 21:40
- NTIDsHelmut 2022-01-29 12:19
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 21:40
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Helmut 2022-01-28 21:06
Ing. Helmut Schütz