Bioequivalence and Bioavailability Forum

Dear All

Just got a goodie on LinkedIn and I assumed that it would be useful

As per, Ajaz S. Hussain (Ph.D. Executive Director at NIPTE & Founder CEO at Insight Advice & Solutions LLC)FDA is expected to issue a long awaited revised BCS draft guidance in the next few weeks. Expected changes may include the following:

1. Addition of ‘very rapid’ dissolution criteria (>85% in 15 minutes)
   
2. Change permeability boundary from 90% to 85% (in line with WHO)
   
3. Change the pH solubility range from 1 – 7.5 to 1 – 6.8
   
4. Possibility of changing paddle speed from 50 to 75 rpm
   
5. Additional topics / clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), MR (Modified Release) products.
   
6. Update the list of model drugs.
   
7. Strengthen GI stability requirement.

Apart from this other key objective is to provide guidance for biowaivers of BCS Class 3 drugs with additional changes to facilitate greater international harmonization