Bioequivalence and Bioavailability Forum

Dear all,

on March 13, 2025 the ICH Assembly endorsed M13B (published yesterday)

BIOEQUIVALENCE FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS
Additional Strengths Biowaiver

for public consultation. From the ICH website:

[…] the ICH M13B Guideline is intended to provide recommendations […] during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. The ICH M13B Guideline is the  first  [second!] Guideline in the foreseen series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. How regulatory decisions may be made based on BE assessment is out of the scope of this guideline.

See also a presentation prepared by the ICH M13 Expert Working Group.

The duration of the consultation period varies amongst jurisdictions (please check their respective websites) and can be between two and six months.* The final guideline (step 4) is expected for QIV / 2026.

Interesting is the decision tree for determining dissolution profile similarity using ƒ₂. In terms of variability, different from the BCS-based biowaiver guideline M9 of 2019.

Can you guess where ≥46 comes from? I have some goofy ideas. 

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Public consultation dates as of 9 April 2025:

• HSA, Singapore: 15 June 2025
  
• EC, Europe: 9 July 2025
  
• TFDA, Chinese Taipei: 31 July 2025