Bioequivalence and Bioavailability Forum • Necessity of ISR

Necessity of ISR [Bioanalytics]

posted by olacy – Hungary, 2012-03-01 12:43 (5230 d 07:22 ago) – Posting: # 8196
Views: 4,071

Hi,

Could you please advise whether a pivotal study conducted before 2011 (without ISR) can be submitted after Mar 2012 when the new bioanalytical guideline is already effective (and it requires ISR)?

Thanks!

Complete thread:

Necessity of ISRolacy 2012-03-01 11:43
- Necessity of ISR Ohlbe 2012-03-01 12:28
  - Necessity of ISR olacy 2012-03-01 13:31

Activity

Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
366 visitors (0 registered, 366 guests [including 31 identified bots]).
Forum time: 21:05 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge. Charles Darwin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz