Interim Safety Analysis or Re-Screening [Design Issues]

posted by drgunasakaran1  – 2025-01-10 01:01 (180 d 16:40 ago) – Posting: # 24337
Views: 1,828

❝ We are planning to conduct a bioequivalence study for submission in Egypt. The molecules of interest necessitate a washout period of approximately three months in a crossover design. Should we perform re-screening/interim safety analysis before the dosing of Period II?


For Studies on drugs with long elimination half-lives, Egyptian guideline for conducting bioequivalence studies for marketing authorization of generic products states that "Normally the interval between study days should not exceed 3 – 4 weeks." I recommend opting for a parallel design instead of a crossover design with a washout period of three months. This approach will also eliminate the need for re-screening.


Reference: Egyptian Drug Authority, Central Administration of Pharmaceutical Products. Egyptian Guidelines on Conducting Bioequivalence Studies for Marketing Authorization of Generic Products. Cairo. February 2017. Online.
[Helmut]

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,688 registered users;
47 visitors (0 registered, 47 guests [including 7 identified bots]).
Forum time: 18:42 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5