Critical dose drugs [Regulatives / Guidelines]
Dear Nirav,
If you aimed for a submission in Canada I think the
"Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects"
paragraph 2.1.1.6 Critical dose drugs
applies.
Hope this helps.
❝ Can you plz tell me the Statistical criteria to be kept for BE study of Anticoagulant molecule having steep exposure response relationship for both safety and efficacy for canada submission.
❝ Can i follow OGD for BE study conducted for Canada submission?
If you aimed for a submission in Canada I think the
"Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects"
paragraph 2.1.1.6 Critical dose drugs
applies.
Hope this helps.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Regarding Statistical criteria for BE study of anticoagulant molecule suchit_bhavsar 2017-04-24 07:29 [Regulatives / Guidelines]
- Critical dose drugsd_labes 2017-04-24 11:26
- Critical dose drugs suchit_bhavsar 2017-04-24 12:04
- Critical dose drugs - FDA highly variable NTID d_labes 2017-04-25 08:41
- Critical dose drugs suchit_bhavsar 2017-04-24 12:04
- Critical dose drugsd_labes 2017-04-24 11:26