Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

Published 2016 View Full Article

Title

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

Authors

Keywords

biowaivers, immediate release oral dosage forms, multi-unit dissolution testing, strength-dependent dissolution acceptance criteria, strength-dependent dissolution profiles

Journal

AAPS Journal

Volume 18, Issue 3, Pages 578-588

Publisher

American Association of Pharmaceutical Scientists (AAPS)

Online

2016-03-01

DOI

10.1208/s12248-016-9893-2

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