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zheng791
Junior

US,
2018-07-13 21:31

Posting: # 19052
Views: 885
 

 Not 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
ElMaestro
Hero

Denmark,
2018-07-13 22:29

@ zheng791
Posting: # 19055
Views: 782
 

 Not using Bio­strength for BE

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.

if (3) 4

Best regards,
ElMaestro

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jag009
Hero

NJ,
2018-07-17 06:32

@ zheng791
Posting: # 19073
Views: 667
 

 Not using Bio­strength for BE

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
Junior

India,
2018-07-17 06:46

@ zheng791
Posting: # 19076
Views: 670
 

 Not using Bio­strength for BE

» 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.
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