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RegisterGuidance for eCTD [Regulatives / Guidelines]
Dear Helmut & All,
Please guide us to prapare eCTD format for bioequivalence study for FDA submission.
Currently we refer "Guidence for industry Preparation of new drug submissions in the CTD format". Is it necessary to give all information mentioned in Module 1 to Module 5 for bioequivalence study from this guideline.
Please let us know where can we get exact information about eCTD (ANDA) submission for bioequivalence studies.
Shankaranarayanan J
Sitec Labs Pvt Ltd,
Mumbai, India.
Please guide us to prapare eCTD format for bioequivalence study for FDA submission.
Currently we refer "Guidence for industry Preparation of new drug submissions in the CTD format". Is it necessary to give all information mentioned in Module 1 to Module 5 for bioequivalence study from this guideline.
Please let us know where can we get exact information about eCTD (ANDA) submission for bioequivalence studies.
Shankaranarayanan J
Sitec Labs Pvt Ltd,
Mumbai, India.
Complete thread:
- Guidance for eCTDshankar 2008-03-10 10:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Guidance for eCTD MGR 2008-03-10 10:57
- Guidance for eCTD shankar 2008-03-11 09:40
- Guidance for eCTD MGR 2008-03-10 10:57
Ing. Helmut Schütz