Helmut
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2018-09-03 16:46
(2059 d 08:15 ago)

Posting: # 19230
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 FDA: Dissolution Testing and Acceptance Criteria for IR… [BE/BA News]

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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.
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