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RegisterNot using Biostrength for BE [Regulatives / Guidelines]
Hi,
Our firm is developing a multi-strength product which is a high potency, NTI oral dosage. The highest strength is 0.3 mg. The product guidance requests to use 0.3 mg x2 tablets for dosing and biowaive the lower strengths. However, our firm does not want to develop 0.3 mg. They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths? These strengths are similarly proportional, that is have the same tablet weight, the filler weight changes to compensate the API change.
Thank you
Our firm is developing a multi-strength product which is a high potency, NTI oral dosage. The highest strength is 0.3 mg. The product guidance requests to use 0.3 mg x2 tablets for dosing and biowaive the lower strengths. However, our firm does not want to develop 0.3 mg. They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths? These strengths are similarly proportional, that is have the same tablet weight, the filler weight changes to compensate the API change.
Thank you
Complete thread:
- Not using Biostrength for BEzheng791 2018-07-13 21:31 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Not using Biostrength for BE ElMaestro 2018-07-13 22:29
- Not using Biostrength for BE jag009 2018-07-17 06:32
- Not using Biostrength for BE sameep 2018-07-17 06:46
Ing. Helmut Schütz