Guideline for Russia and Mexico [Regulatives / Guidelines]
What is the Bio equivalence criteria for generics drugs in Russia and Mexico (Specifically for highly variable drugs)?
Do we need to conduct the BE study on mexican and russian population only?
Which innovators (reference) products should be used in Mexico and Russia for BE study? Can we make use of US innovator in study in Mexico or Russia?
Do we need to conduct the BE study on mexican and russian population only?
Which innovators (reference) products should be used in Mexico and Russia for BE study? Can we make use of US innovator in study in Mexico or Russia?
Complete thread:
- Guideline for Russia and Mexicomunish244 2012-08-23 08:26
- Search! Helmut 2012-08-23 16:42
