Bioequivalence and Bioavailability Forum • Montelukast BE study

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

posted by elam – Saudi Arabia, 2016-12-04 09:59 (3488 d 03:39 ago) – Posting: # 16831
Views: 11,772

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

Complete thread:

Montelukast BE study - Cmax shows supra bioavailability elam 2016-12-01 08:20
- Montelukast BE study - Cmax shows supra bioavailability nobody 2016-12-01 10:03
  - Montelukast BE study - Cmax shows supra bioavailability Dr_Dan 2016-12-01 13:56
  - Montelukast BE study - Cmax shows supra bioavailability elam 2016-12-04 08:32
- Montelukast BE study - Cmax shows supra bioavailability ElMaestro 2016-12-01 14:50
  - Montelukast BE study - Cmax shows supra bioavailability nobody 2016-12-01 15:34
- Montelukast BE study - Cmax shows supra bioavailabilityelam 2016-12-04 08:59