Dissolution Tests As A Drug Development Tool: Concept Gets FDA Panel Review
This article was originally published in The Pink Sheet Daily
Executive Summary
The assessment technique has mostly been seen as a confirmatory, not exploratory, process, but FDA will ask its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to weigh in on research needed to correlate in vitro dissolution testing with in vivo drug performance.
You may also be interested in...
Dissolution Testing Flunks FDA Advisory Committee Exam As Development Tool
The difficulties in adapting in vitro dissolution tests to use in drug development are that they tend to be individual for a drug and dosage form and that they replicate only one portion of in vivo activity, members of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology tell FDA.
FDA’s Top-Four Tablet Scoring Concerns To Get Advisory Committee Review
The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will vote on some aspects of FDA’s draft scoring guidance, potentially giving generic industry a clue of future agency actions.
FDA Takes Its Tablet-Scoring Guidance To An Advisory Committee
On Aug. 9, FDA’s Pharmaceutical Science and Clinical Pharmacology panel will discuss the agency’s year-old draft guidelines on the data needed to support functional scoring of tablets. Issues related to tablet scoring as a purported strategy for delaying generic entry are at the heart of Mylan’s recent lawsuit against Doryx marketer Warner Chilcott.