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RegisterBiowaiver for oral aqueous solution [Regulatives / Guidelines]
Dear forum,
We have developed an oral acqueous solution and there are no approved oral solution in the market. The comparator is a suspension
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** mentions that, ‘If the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution, bioequivalence studies may be waived.’
Considering that approved oral solution isnt available, will biowaiver be a remote possibility?
Kind regards,
Tina
We have developed an oral acqueous solution and there are no approved oral solution in the market. The comparator is a suspension
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** mentions that, ‘If the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution, bioequivalence studies may be waived.’
Considering that approved oral solution isnt available, will biowaiver be a remote possibility?
Kind regards,
Tina
Complete thread:
- Biowaiver for oral aqueous solutionTina 2013-10-03 16:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for oral aqueous solution drgunasakaran1 2013-10-03 19:33
- Biowaiver for oral aqueous solution ElMaestro 2013-10-03 20:00
Ing. Helmut Schütz