Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics.

Autor: Rogers-Crovak JA; Novatia, LLC, 54 Walker Ln, Newtown, Pennsylvania, 18940, USA., Delaney EJ; Novatia, LLC, 54 Walker Ln, Newtown, Pennsylvania, 18940, USA., Detlefsen DJ; Novatia, LLC, 54 Walker Ln, Newtown, Pennsylvania, 18940, USA. detlefsend@enovatia.com.

Publikováno v: The AAPS journal [AAPS J] 2024 Nov 26; Vol. 27 (1), pp. 8. Date of Electronic Publication: 2024 Nov 26.