Montelukast BE study - Cmax shows supra bioavailability [Regulatives / Guidelines]

posted by elam – Saudi Arabia, 2016-12-04 09:59 (3019 d 20:03 ago) – Posting: # 16831
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Hi to all,

Thanks for your comments.

Almost all comments are emphasizing that, Montelukast is not a BCS class I molecule.

I have Understood that, we everyone have different references and dissolution study results are varying.

Moreover, Please find the USFDA reference for BCS class I category.

https://bpca.nichd.nih.gov/collaborativeefforts/initiatives/documents/formulations_platform_report1.pdf

My earlier below mentioned questions are general. Could you please share your comments.

❝ what are the chances are there for failure of BCS class I molecule. Any one having experience of BCS class I molecule BE study failure?


❝ In-vitro shows similar but in-vivo fails?


In addition, We are looking for identifying the discriminative media. Any one can advice on these?

Once again thanks for your all responses.


regards
Elam

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