RLD selection for Europe / Canada [Regulatives / Guidelines]
Thanks for your reply
If we want to market the product in Canand & Europe (i.e)
Canada Innovator Tablets vs Test powder for suspension then we will market the product in canada if meets BE critria 80 - 125 % its called as Relative bioavaialbility it correct.
For Europe all we can do the same its acceptable,because in canada TPD given some critria to met.
From your reply i understand Innovator tablets of Canada vs Test product of powder for oral suspension (Relative BA) meets BE critria 80 - 125% its correct.
IF Reference produt not available in Europe & Canada but available in US.
How do the Bioequivalence study for the product?
How to choose Reference for Europe?
How to Choose Reference for Canada?
What is the critria required for RLD Selection & BE study required?
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! I copypasted your text from another post which I deleted (see here). [Helmut]
If we want to market the product in Canand & Europe (i.e)
Canada Innovator Tablets vs Test powder for suspension then we will market the product in canada if meets BE critria 80 - 125 % its called as Relative bioavaialbility it correct.
For Europe all we can do the same its acceptable,because in canada TPD given some critria to met.
From your reply i understand Innovator tablets of Canada vs Test product of powder for oral suspension (Relative BA) meets BE critria 80 - 125% its correct.
IF Reference produt not available in Europe & Canada but available in US.
How do the Bioequivalence study for the product?
How to choose Reference for Europe?
How to Choose Reference for Canada?
What is the critria required for RLD Selection & BE study required?
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! I copypasted your text from another post which I deleted (see here). [Helmut]
Complete thread:
- RLD selection for Europe / Canada alagu 2013-08-14 10:27
- RLD selection for Europe / Canada Dr_Dan 2013-08-14 11:40
- RLD selection for Europe / Canadaalagu 2013-08-14 11:55
- RLD selection for Europe / Canada Dr_Dan 2013-08-14 11:40
