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Bioequivalence testing of Glivec generic likely to be made compulsory
Published: 2010-06-07 06:59:00
Updated: 2010-06-07 06:59:00
Drugmakers who intends to produce the generic version of Glivec (imatinib mesylate) will be required to conduct equivalence testing over patients instead of healthy volunteers.
“It must be necessary for pharmaceutical manufacturers to reassess the safety and efficacy of Glivec generics in cancer patients,” a KFDA official said.
Glivec used in treating chronic myelogenous leukemia (CML), g...
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