ICH M13 Bioequivalence for Immediate-Release Solid Oral Dosage

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M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms

M13 EWG Bioequivalence for Immediate-Release Solid Oral Dosage Forms

This topic was endorsed by the ICH Assembly in November 2019.


Further to the MC's endorsement of the M13 Concept Paper and Business Plan in July 2020, the M13 EWG was established to work on the development of the M13 Guideline to harmonise bioequivalence study design and standards, which is expected would benefit both innovator and generic product developers as the same scientific approach would be followed in multiple jurisdictions, potentially reducing duplicative work. Patients would also benefit as harmonisation would help regulatory agencies in the timely authorisation and availability of quality, safe and effective drugs based upon harmonised acceptance criteria. Furthermore, harmonisation could improve global access to drugs.


Further information can be found in the M13 Concept Paper and Business Plan.


Endorsed Documents (Click the links below for complete guidelines)

M13 Concept Paper

M13 Business Plan

M13 Work Plan



*These Guidelines Belongs to ICH website.


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