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RegisterDose ≠ strength [Regulatives / Guidelines]
Hi
I had several discussions on this topic. If you have just one formulation for your product and the strengths of your product are solely characterized by proportional amount (ml) or e.g. patch size (cm2) are these really different strengths or just different doses? IMHO agencies tend to the first option. In consequence you have to conduct your BE study with the highest strength (i.e. greatest amount, biggest patch size) in order to waive the lower strengths. This is why I had to repeat a fentanyl study with the 100 µg patch although the 25 µg already demonstrated BE.
I had several discussions on this topic. If you have just one formulation for your product and the strengths of your product are solely characterized by proportional amount (ml) or e.g. patch size (cm2) are these really different strengths or just different doses? IMHO agencies tend to the first option. In consequence you have to conduct your BE study with the highest strength (i.e. greatest amount, biggest patch size) in order to waive the lower strengths. This is why I had to repeat a fentanyl study with the 100 µg patch although the 25 µg already demonstrated BE.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Paliperidone injection - waiver option msmnainar 2016-07-01 08:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Paliperidone injection - waiver option Helmut 2016-07-01 10:17
- Paliperidone injection - waiver option nobody 2016-07-01 11:08
- Dose ≠ strengthDr_Dan 2016-07-04 10:16
- Paliperidone injection - waiver option nobody 2016-07-01 11:08
- Paliperidone injection - waiver option Helmut 2016-07-01 10:17
Ing. Helmut Schütz