H[a]VD and MDT [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-07-29 13:04 (239 d 09:45 ago) – Posting: # 23188
Views: 1,080

Hi Vaibhav,

❝ For modifed release formulation (Bioequivalence of partial AUC) […]

❝ Comparisons of HaVD and MDT can be evaluated by nonparametric calculations

❝ Which part of the curve bioequivalence needs to be established, upper or lower?

❝ Is it acceptable approach for EU submission.

Since you posted in the category Regulatives / Guidelines and asked specifically for a European submission:Personally I agree with the ‘Two Lászlós’ and think that these metrics are valuable indeed (though I don’t concur that nonparametrics are necessary). If you want to discuss these metrics, let me know and I will move this thread to the category NCA / Sham.

PS: Why did you upload the figure seven times in the lousy JPG-format (see there)? I removed them and uploaded an 8 bit PNG including the legend instead.
PPS: A salutation in posts is polite and never hurts.

  1. Endrényi L, Tóthfalusi L. Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations. AAPS J. 2012; 14(4): 813–9. doi:10.1208/s12248-012-9396-8. [image] Free full text.
  2. Steinijans VW, Sauter R, Diletti E. Shape Analysis in Single- and Multiple-Dose Studies of Modified Release Pro­ducts. In: Blume HH, Midha KK (ed’s). Bio-International 2. Stuttgart: medpharm Scientific Publishers; 1995. pp. 193–206.
  3. Shohin IE, Roshdestvenskij DA, Medvedev VYu, Komarow TN, Grebenkin DYu. Russia, Belarus & Ka­sakh­stan. In: Kanfer I. (ed). Bioequivalence Requirements in Various Global Jurisdictions. Cham: Springer; 2017. pp. 199–227.

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