a very interesting summary, thanks for posting it. I do wonder however if that process may not have shortcomings with respect to warfarin where the different enantiomers (stereochemistry forms similar to your left hand and your right hand being mirror images but well made gloves won't fit on either hand unlike disposable latex ones) are known to have different metabolisms
that its noted that brand substitution causes INR changes I suspect that such approval process does not cover this adequately.Abstract
The anticoagulant drug warfarin occurs as a pair of enantiomers that are differentially metabolized by human cytochromes P450 (CYP). R-warfarin is metabolized primarily by CYP1A2 to 6- and 8-hydroxywarfarin, by CYP3A4 to 10-hydroxywarfarin, and by carbonyl reductases to diastereoisomeric alcohols. S-warfarin is metabolized primarily by CYP2C9 to 7-hydroxywarfarin. ... The efficacy of warfarin is affected primarily when metabolism of S-warfarin is altered.
...In one observational study, however, a change in therapeutic INR control after the switch to generic warfarin was reported at the individual patient level. The results of our systematic review suggest that generic warfarin products may be as safe and effective as brand name products and that patients may be safely treated with these products. However, closer monitoring may be reasonable when switching brands, as variations in individual INR response may be seen.