Bioequivalence and Bioavailability Forum • And Japan?

And Japan? [BE/BA News]

posted by ElMaestro – Belgium?, 2019-12-04 13:43 – Posting: # 20923
Views: 1,907

Wow,

» A: The guideline focuses on BCS-based biowaiver principles to be applied for bioequivalence purposes provided they are supported by a sound scientific rationale. The provision in the guideline that accommodates exceptions to existing regulations that do not permit BCS-based biowaivers for generic product applications, at this time, does not disqualify implementation of these harmonized technical requirements to demonstrate BCS based biowaivers for other product applications unless explicitly stated.

I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??
:-)

—
I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

ICH M13 Helmut 2019-11-27 19:08 [BE/BA News]
- ICH M13 ElMaestro 2019-11-27 21:42
  - ICH pushed by GBHI? Helmut 2019-11-28 12:37
    - ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
      - “Lively” discussions Helmut 2019-11-28 14:23
        
        M9 step 4 now published Ohlbe 2019-12-04 11:26
        
        And Japan? Helmut 2019-12-04 11:42
        
        And Japan?ElMaestro 2019-12-04 14:43
        
        🈴 business as usual Helmut 2019-12-04 15:42