Log in
Register|
zheng791 ☆ US, 2018-07-13 23:31 (2903 d 19:10 ago) Posting: # 19052 Views: 4,695 |
|
|
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 |
|
ElMaestro ★★★ Denmark, 2018-07-14 00:29 (2903 d 18:12 ago) @ zheng791 Posting: # 19055 Views: 3,846 |
|
|
Hi zheng791, ❝ Can I use 0.15 mg x4 for dosing and biowaive lower strengths? No, unless you actively contact OGD and get a yes from them. — Pass or fail! ElMaestro |
|
jag009 ★★★ NJ, 2018-07-17 08:32 (2900 d 10:09 ago) @ zheng791 Posting: # 19073 Views: 3,690 |
|
|
Hi, ❝ Our firm is developing a multi-strength product which is a high potency, NTI oral dosage... 1) Is 0.15mg your only strength? 2) Why you want to dose 0.15x4 and not just 0.15mg? 3) Better to file a control correspondence J |
|
sameep ☆ India, 2018-07-17 08:46 (2900 d 09:54 ago) @ zheng791 Posting: # 19076 Views: 3,784 |
|
|
❝ They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths? The product in question needs to be dosed at 0.6 mg for getting measurable concentrations (endogenous substance, baseline correction,...). Yes, 0.15 mg x 4 tablets can be dosed, Still get a controlled correspondence with FDA. |
Ing. Helmut Schütz