Pharmacokinetics linearity [Regulatives / Guidelines]

posted by pjs – India, 2015-05-28 16:58 (3550 d 11:34 ago) – Posting: # 14869
Views: 4,458

Dear all,

Thanks for your response.

I am talking about interpolating the linearity.

One case i can think of the nonlinearity at lower dose is drug is getting degraded in the GI tract due to some enzyme and only after above certain concentration the enzyme get saturated and linear pharmacokinetics can be availed. Or above certain concentration only can be bound to transporter (due to competition with other GI content to get bound with the transporter).

We will be doing one BE study at higher streangth (25mg/5ml sol vs 25 mg tab )and using that data to support the article 10(3) application But would like to apply for the biowaiver for lower strength. Yes, It would be difficult to prove BE as its BCS class 3 drug. However one company has filed generic application using the same strategy and had also availed biowaiver for lower strength. Just quriuous regarding the data that they may have submitted.

Please revert back in case of further clarification.

Regards,
PJS

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