RSABE… [Regulatives / Guidelines]
❝ 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RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).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. PMC Free Full text.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
- Scaling/Widening of AUC Loky do 2021-02-24 13:13
- Scaling/Widening of AUC Helmut 2021-02-24 15:29