Population/Individual Bioequivalence [General Statistics]
Hello HS,
Thanks for your quick reply and clearing my doubts about regulatory acceptance of IBE/PBE.
Your answer made me to think further about, the issues of Switchability and Prescribability.
How do we tackle/address these issues, Is it relevant to evaluate the generic to generic switchability impact, as none of the guidelines talk about these, Is there any specific method to explore this issue of switchability impact considering the fact that the markets are getting flooded with "N" number of generics
I have seen methods such as Indirect Treatment comparision/Network meta analysis published in the literature and being used for this by Canadian FDA/EMEA
I would like to know from people like you, what's your opinion
Kaushik
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! [Helmut]
Thanks for your quick reply and clearing my doubts about regulatory acceptance of IBE/PBE.
Your answer made me to think further about, the issues of Switchability and Prescribability.
How do we tackle/address these issues, Is it relevant to evaluate the generic to generic switchability impact, as none of the guidelines talk about these, Is there any specific method to explore this issue of switchability impact considering the fact that the markets are getting flooded with "N" number of generics
I have seen methods such as Indirect Treatment comparision/Network meta analysis published in the literature and being used for this by Canadian FDA/EMEA
I would like to know from people like you, what's your opinion
- on assesing the impact of generic to generic switchability by a statistical method
- As a researcher is there any way out to statistically evaluate these growing number of generics getting flooded in the market
Kaushik
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! [Helmut]
Complete thread:
- Individual/Population Bioequivalence Harish Kaushik 2015-02-02 12:16 [General Statistics]
- Population/Individual Bioequivalence Helmut 2015-02-02 13:30
- Population/Individual BioequivalenceHarish Kaushik 2015-02-03 05:52
- Population/Individual Bioequivalence jag009 2015-02-27 00:30
- Switching in theory & practice Helmut 2015-02-27 16:37
- theory & practice.... & practice ElMaestro 2015-02-27 17:07
- theory & practice.... & practice nobody 2015-02-27 19:56
- theory & practice.... & practice ElMaestro 2015-02-27 21:04
- theory & practice.... & practice nobody 2015-02-27 21:34
- theory & practice.... & practice ElMaestro 2015-02-27 21:04
- theory & practice.... & practice nobody 2015-02-27 19:56
- theory & practice.... & practice ElMaestro 2015-02-27 17:07
- Population/Individual BioequivalenceHarish Kaushik 2015-02-03 05:52
- Population/Individual Bioequivalence Helmut 2015-02-02 13:30