EMA released for comment the draft "ICH M13B Guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver" guideline. There is a 90-day comment window.
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m13b-bioequivalence-immediate-release-solid-oral-dosage-forms-additional-strengths-step-2b_en.pdf
#ICH #M13B #Biowaiver #Bioequivalence
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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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