AAPS PharmSciTechSolubilityTherapeutic EquivalencyChemistryPharmaceuticalDrug Liberation
Scientific and Regulatory Standards for Dissolution Similarity: a Statistical Game of Matchmaking Neither Force to Pass or Nor Fail to Pass.
Dharmaraj More, Bhagyesh Trivedi, Ajay Khopade
Published: 202610.1208/s12249-026-03324-7
Abstract
The principal of generic product development is to match the critical quality attributes. Most of the time during complex product development, life cycle management; biowaiver, pre- and post-change approvals the significant efforts are made by scient…
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