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Registerunknown linearity [Regulatives / Guidelines]
Dear all,
There are two products (x mg and y mg capsules) for which BE study will be conducted. We want to submit one of the dosage forms as a biowaver.
Although the other criteria is all fulfilled as per the general biowaver criteria defined in the 4.1.6th article of the guideline, linearity of the active is not known. Can you please advise how to proceed?
There are two products (x mg and y mg capsules) for which BE study will be conducted. We want to submit one of the dosage forms as a biowaver.
Although the other criteria is all fulfilled as per the general biowaver criteria defined in the 4.1.6th article of the guideline, linearity of the active is not known. Can you please advise how to proceed?
Complete thread:
- unknown linearitykudra23 2012-01-30 10:30 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- linear PK required for biowaiver Helmut 2012-01-31 02:45
- ... or knowledge of non-linearity Ohlbe 2012-01-31 17:47
- ... or knowledge of non-linearity kudra23 2012-01-31 18:18
- ... or knowledge of non-linearity Ohlbe 2012-01-31 17:47
- linear PK required for biowaiver Helmut 2012-01-31 02:45
Ing. Helmut Schütz