ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test - general chapter

We have adopted this International Scientific Guideline – ICH Q4B Annex 7 (R2); EMA/CHMP/ICH/645469/2008

Last updated

11 December 2024

About this guideline

Overseas effective date: September 2010

Replaces: EMEA/CHMP/ICH/645469/2008 (November 2009 version)

Categories: ICH | Quality

Quality | Specifications and analytical procedures and analytical validation

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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