FDA: Dissolution Testing and Acceptance Criteria for IR… [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2018-09-03 14:46 (1145 d 20:45 ago) – Posting: # 19230
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Dear all,

in August the FDA published the final Guidance for Industry

“Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances”

Since – like most agencies – the FDA doesn’t provide a change control here is the draft of August 2015 for comparison.

Dif-tor heh smusma 🖖
Helmut Schütz
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