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RegisterPharmacokinetic interaction study [Regulatives / Guidelines]
Dear Mahesh M
If you develop a new FDCP (and not a generic of another FDCP) you are obliged to investigate possible DDI. AFAIK/my experience: A DDI study is not a konfirmatory study, you only need to describe the pharmacokinetic interaction by means of each single entity and the same statistical confidence intervals. But you do not need to show bioequivalence by means of the acceptance range of 80-125%. If you meet the bioequivalence criteria everything is fine. If you are not (strictly) bioequivalent, you need to discuss the results with respect to risk and benefit of the new FDCP. However, if your new FDCP is a combination of two inhaler drugs in a same capsule I do not think that a simple DDI study would be sufficient since the systemic availability of the drugs might not reflect their combined local effect. A clinical phase III study can not be avoided.
I hope this helps.
Kind regards
Dr_Dan
If you develop a new FDCP (and not a generic of another FDCP) you are obliged to investigate possible DDI. AFAIK/my experience: A DDI study is not a konfirmatory study, you only need to describe the pharmacokinetic interaction by means of each single entity and the same statistical confidence intervals. But you do not need to show bioequivalence by means of the acceptance range of 80-125%. If you meet the bioequivalence criteria everything is fine. If you are not (strictly) bioequivalent, you need to discuss the results with respect to risk and benefit of the new FDCP. However, if your new FDCP is a combination of two inhaler drugs in a same capsule I do not think that a simple DDI study would be sufficient since the systemic availability of the drugs might not reflect their combined local effect. A clinical phase III study can not be avoided.
I hope this helps.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Pharmacokinetic interaction study Mahesh M 2016-05-12 07:07 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDCPs: generally BE (higher BA under certain conditions) Helmut 2016-05-12 13:15
- FDCPs: generally BE (higher BA under certain conditions) nobody 2016-05-12 13:41
- FDCPs: generally BE (higher BA under certain conditions) Mauricio Sampaio 2016-05-19 05:47
- FDCPs: generally BE (higher BA under certain conditions) nobody 2016-05-12 13:41
- Pharmacokinetic interaction studyDr_Dan 2016-05-19 10:05
- Pharmacokinetic interaction study nobody 2016-05-20 09:40
- FDCPs: generally BE (higher BA under certain conditions) Helmut 2016-05-12 13:15
Ing. Helmut Schütz