Bioequivalence and Bioavailability Forum • 5 %: both formulations

5 %: both formulations [Regulatives / Guidelines]

posted by Ohlbe – France, 2014-01-20 17:21 (4541 d 02:34 ago) – Posting: # 12208
Views: 5,363

Dear Melkor,

I think the guideline is quite clear on this aspect:

If there is some deviation from quantitatively proportional composition, condition c is still considered fulfilled if condition i) and ii) or i) and iii) below apply to the strength used in the bioequivalence study and the strength(s) for which a waiver is considered
i. the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content

My understanding is that both the formulation used in the BE trial and the formulation you want to waive should contain less than 5 % of "active substance", whatever that may be.

—
Regards
Ohlbe

Complete thread:

Biowaiver for low-strength (<5%) Melkor 2014-01-20 13:59
- API = salt? Helmut 2014-01-20 14:24
  - API = salt? Melkor 2014-01-20 15:28
    - 5 %: both formulationsOhlbe 2014-01-20 16:21
      - 5 %: both formulations Helmut 2014-01-20 17:04
        
        5 %: both formulations Ohlbe 2014-01-20 17:32
        
        5 %: both formulations Melkor 2014-01-22 12:34
        Active moiety Helmut 2014-01-23 00:54
        
        Change of API and fate of biostudy kumarnaidu 2014-06-27 10:54