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Title: Response to the letter to the editor regarding our article 'statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study' https://doi.org/10.1002/pst.2233.
Authors: Jones, Byron; Li, Bingbing; Bagger, Morten; Goodyear, Alex; Ludwig, Inga
Abstract: We thank Wanjie Sun, Donald J. Schuirmann, and Stella Grosser for their detailed review and valuable comments and opinions on Jones et al. (2022),1 and for explaining the existing FDA guidelines for PK comparability studies. We thank Wanjie Sun, Donald J. Schuirmann, and Stella Grosser for sharing the information given by the FDA in their final review and agree with them that both the ABE and the RSABE analysis methods show that bioequivalence was met in the APLIOS study.
Subjects: CLINICAL trials
Publication: Pharmaceutical Statistics, 2022, Vol 21, Issue 6, p1368
ISSN: 1539-1604
Publication type: Academic Journal
DOI: 10.1002/pst.2254

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Response to the letter to the editor regarding our article 'statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study' https://doi.org/10.1002/pst.2233.