Bioequivalence and Bioavailability Forum • Change of API and fate of biostudy

Change of API and fate of biostudy [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2014-06-27 12:54 (4374 d 16:20 ago) – Posting: # 13154
Views: 4,786

Hi all,
I have one passed BE study. After that if I change the source of API do we need to conduct a repeat BE study or earlier passed BE study will suffice.

—
Kumar Naidu

Complete thread:

Biowaiver for low-strength (<5%) Melkor 2014-01-20 13:59 [Regulatives / Guidelines]
- API = salt? Helmut 2014-01-20 14:24
  - API = salt? Melkor 2014-01-20 15:28
    - 5 %: both formulations Ohlbe 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 biostudykumarnaidu 2014-06-27 10:54