Bioequivalence and Bioavailability Forum

Not using Biostrength for BE [Regulatives / Guidelines]

posted by sameep – India, 2018-07-17 08:46 (1785 d 05:51 ago) – Posting: # 19076
Views: 2,162

❝ 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.

Complete thread:

Not using Biostrength for BE zheng791 2018-07-13 21:31 [Regulatives / Guidelines]
- 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 BEsameep 2018-07-17 06:46

Not using Bio­strength for BE [Regulatives / Guidelines]

Complete thread:

Not using Biostrength for BE [Regulatives / Guidelines]