Retrospective analysis of the biopharmaceutics characteristics of solid oral Modified-Release drug products in approved US FDA NDAs designated as Extended-Release or Delayed-Release formulations

Ahmed, N; Ly, H; Pan, A; Chiang, B; Raines, K; Janwatin, T; Hamed, S; Dave, K

Ahmed, N (通讯作者)，US FDA, Silver Spring, MD 20993 USA.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 2023; 193 (): 294

Abstract

Background: Modified Release (MR) orally administered drugs products [Extended-Release (ER) and DelayedRelease (DR)] differ from Immediate-Release (IR......

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