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[DOCX File]Comprehensive Summary: Bioequivalence
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For comparison of dissolution profiles, the similarity factor (f2) should be estimated per the ICH M9 guidance : Biopharmaceutics Classification System-Based biowaivers , where applicable.
ich guidance documents on quality

[DOC File]Good Clinical Practice (GCP) Guidelines
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The objective of the ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. ... stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter ...
ich stability guidance

[DOC File]ANNEX D
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The dissolution of AB1234 Capsules is determined using Apparatus II of the USP, with a dissolution medium of 900 mL of ammonium acetate buffer at pH 4.0 and a paddle speed of 50 rpm. Detection is by UV absorbance at 262 nm. ... Provide justification if ICH/CPMP guidance document not followed.]
ich guidance documents on quality

[DOC File]EN - European Commission
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The dissolution profile of the new product determined on a minimum of two pilot scale batches is comparable to the old one (no significant differences regarding comparability, see the relevant (Human or Veterinary) guidance on Bioavailability).
ich stability guidance

[DOCX File]Minor Variation Guideline (chemical)
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The dissolution profile of the proposed drug product is comparable to that of the approved drug product. For minor qualitative or quantitative changes of excipient for immediate release oral solid dosage forms (as per Level 1, Part III Components and Composition, SUPAC guideline) or other non-critical dosage forms, refer to MIV-2 C14.
ich guidance documents on quality

[DOCX File]Minor Variation Guideline (chemical)
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The dissolution profile of the proposed drug product is comparable to that of the approved drug product. For qualitative or quantitative changes of excipient for immediate release (Level 2 and 3 change as per US FDA SUPAC IR Guideline) and modified release oral solid dosage forms, and other critical dosage forms, refer to MIV-1 B13.
ich stability guidance

[DOCX File]Product Quality Research Institute – Just another ...
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ICH. Q12 - Moheb Nasr, GlaxoSmithKline. Change Management - Liam Feely, AbbVie. ... Dissolution Testing and Specification for Extended Release Products ... Challenges Integrating Regulatory Filings and Pre-Approval Inspection with the Expectations of Current Regulatory Guidance - Tony Mire-Sluis, Amgen. Product and Process Development. October ...
ich guidance documents on quality

[DOC File]INTERNATIONAL CONFERENCE ON HARMONISATION OF …
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The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 2.9.3. Dissolution Test for Solid Dosage Forms, JP 6.10 Dissolution Test, and USP Dissolution can be used as interchangeable in the ICH regions subject to the following conditions:
ich stability guidance

Ich dissolution guidance