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Registerin vivo data before tweaking in vitro [Dissolution / BCS / IVIVC]
Hello Mr.Helmut,
Firstly very thankful for your quick response.
Your input is valid but the thing is the dissolution method in which my generic product is faster is given in the FDA guidance and I am bound to meet f2 value w.r.t to that of the reference product.
One more thing is that the drug shows local action in the gut so invitro profile is more relevant to show comparison with that of the reference product.
The main reason I am presuming is the variation in the solubility of drugs in reference and test product to be the major reason for the variation in the dissolution profile due to polymorphic difference.The drug in the reference product has low solubility.
Regards,
Kiran.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Firstly very thankful for your quick response.
Your input is valid but the thing is the dissolution method in which my generic product is faster is given in the FDA guidance and I am bound to meet f2 value w.r.t to that of the reference product.
One more thing is that the drug shows local action in the gut so invitro profile is more relevant to show comparison with that of the reference product.
The main reason I am presuming is the variation in the solubility of drugs in reference and test product to be the major reason for the variation in the dissolution profile due to polymorphic difference.The drug in the reference product has low solubility.
Regards,
Kiran.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Complete thread:
- Dissolution profie matching Kiran 2017-06-24 18:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- in vivo data before tweaking in vitro Helmut 2017-06-24 19:30
- in vivo data before tweaking in vitroKiran 2017-06-24 20:19
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- locally acting / diss. similarity mandatory Kiran 2017-06-25 16:40
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- in vivo data before tweaking in vitroKiran 2017-06-24 20:19
- Dissolution profie matching ElMaestro 2017-06-25 20:21
- Dissolution profie matching Kiran 2017-06-26 05:11
- in vivo data before tweaking in vitro Helmut 2017-06-24 19:30
Ing. Helmut Schütz