RLD selection for Europe / Canada [Regulatives / Guidelines]

posted by alagu – India, 2013-08-14 13:55 (4701 d 19:43 ago) – Posting: # 11280
Views: 3,263

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
390 visitors (0 registered, 390 guests [including 15 identified bots]).
Forum time: 09:39 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5