AAPS Advocacy

AAPS experts comment on high-impact scientific guidances from regulatory agencies around the world.

If you’d like to join us in providing pharmaceutical science expertise, please contact us:

Stacey May, Director of Public Outreach

Food and Drug Administration (FDA)

Statistical Approaches to Evaluate Analytical Similarity: Draft Guidance for Industry 

View Guidance (PDF)

View Comments (PDF)

European Medicines Agency (EMA) 

Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development 

View EMA Guidance (PDF)

View Comments (PDF)

British Pharmacopoeia (BP)

Consultation Dissolution testing in BP finished products monographs for solid oral dosage forms

View BP Guidance web page

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