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RegisterUpper bound in RSABE ≤0 [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2019-02-02 15:15 (2343 d 17:45 ago) – Posting: # 19844
Views: 7,534
Hi Nirali,
No, since the upper bound has to be less or equal to zero. No rounding here …
≤0 is the general rule for the FDA’s RSABE.
See also Jay’s post above, this thread, and a paper of the two Lászlós.*
❝ If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?
No, since the upper bound has to be less or equal to zero. No rounding here …
❝ There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.
≤0 is the general rule for the FDA’s RSABE.
See also Jay’s post above, this thread, and a paper of the two Lászlós.*
- Endrényi L, Tóthfalusi L. Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden. J Pharm Pharm. 2013;16(5):676–82. PMID 24393551.
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Helmut Schütz
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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:
- FDA: RSABE for NTID Jay 2018-03-26 13:31 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: RSABE for NTID jag009 2018-03-26 17:57
- FDA: RSABE for NTID Jay 2018-04-02 06:28
- FDA: RSABE for NTID pjs 2018-04-02 15:07
- FDA: RSABE for NTID Jay 2018-04-04 14:24
- β = 1 – π Helmut 2018-04-04 15:03
- Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
- Upper bound in RSABE ≤0Helmut 2019-02-02 14:15
- Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10
- Upper bound in RSABE ≤0Helmut 2019-02-02 14:15
- Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
- β = 1 – π Helmut 2018-04-04 15:03
- FDA: RSABE for NTID Jay 2018-04-04 14:24
- FDA: RSABE for NTID pjs 2018-04-02 15:07
- FDA: RSABE for NTID Jay 2018-04-02 06:28
- FDA: RSABE for NTID jag009 2018-03-26 17:57
Ing. Helmut Schütz