professionalr
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India,
2025-01-09 23:56
(181 d 19:04 ago)

Posting: # 24336
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 Interim Safety Analysis or Re-Screening [Design Issues]

Hi all,

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?


Edit: Category changed; see also this post #1[Helmut]

Thanks,
RP.
drgunasakaran1
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2025-01-10 01:01
(181 d 17:59 ago)

@ professionalr
Posting: # 24337
Views: 1,838
 

 Interim Safety Analysis or Re-Screening

❝ 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
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