From the webinar announcement page:
"This webinar will provide an in-depth look at the draft ICH M13B guideline titled "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver" that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025."
NOTE in the Learning Objectives that in addition to discussing the ICH Working Group thinking, differences from existing FDA practices will be addressed.
"Learning Objectives:
- Provide an overview of the draft ICH M13B guideline
- Explain the ICH Expert Working Group's current scientific thinking behind the guideline
- Highlight main areas that differ from FDA's current guidance on selected topics and their impact
- Clarify the rationale for the guideline's recommendations
- Explain the process for submitting public comments on the draft guideline"
#fda #ICH #M13B #Biowaiver
https://www.fda.gov/drugs/news-events-human-drugs/ich-m13b-webinar-navigating-draft-ich-m13b-additional-strengths-biowaiver-guideline-09112025
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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