E-DRUG: Clinical equivalence of generic and brand-name CVS drugs-JAMA (6)
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Dear Andy and all,
by suggesting that it "would be extremely interesting to look at the proof
of clinical equivalence also in different contexts and diseases", we did not mean to ask to repeat bioequivalence studies that have already been carried out and approved by stringent regulatory authorities or bodies: we agree with you that it would be completely unuseful. Our remark concerns those medicinal products that have not been submitted to stringent authorities nor to the WHO pre-qualification (irrespectively of whether they have been manufactured in rich or in poor countries) and that constitute the majority of products circulating among vulnerable populations.
Best regards,
Jacques Pinel, pharmacist
Raffaella Ravinetto, pharmacist, Institute of Tropical Medicine, Antwerp
Jean-Michel Caudron, pharmacist
rravinetto@itg.be