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RegisterRSABE… [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2021-02-24 15:47 (51 d 15:33 ago) – Posting: # 22231
Views: 637
Hi Loky do,
» I didn't find this statement in FDA guidance for bioequivalence studies …
RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).
Don’t waste your money and get the book mentioned there – the chapter is not helpful. Get the paper by Davit et al.* instead. Free and better.
» … just in progesterone guidance so, is it enough to refer to this guide while submitting the st udy to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way?
Any one would do, IMHO.
» I didn't find this statement in FDA guidance for bioequivalence studies …
RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).
Don’t waste your money and get the book mentioned there – the chapter is not helpful. Get the paper by Davit et al.* instead. Free and better.
» … just in progesterone guidance so, is it enough to refer to this guide while submitting the st udy to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way?
Any one would do, IMHO.
- Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwakama PE, Patel DT, Schuirmann DJ, Yu LX. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration. AAPS J. 2012; 14(4): 915–24. doi:10.1208/s12248-012-9406-x.
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Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Scaling/Widening of AUC Loky do 2021-02-24 13:13
- Scaling/Widening of AUC Helmut 2021-02-24 15:29
- Scaling/Widening of AUC Loky do 2021-02-24 16:13
- Scaling/Widening of AUC dshah 2021-03-16 06:39
- Scaling/Widening of AUC Helmut 2021-03-16 13:55
Ing. Helmut Schütz