HIGHLIGHTS
- who: Narrow therapeutic index drugs et al. from the (UNIVERSITY) have published the article: Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective, in the Journal: (JOURNAL) of 19/09/2005
- what: EMA defines the objective of this initiative as follows: "Product specific guidance for the bioequivalence assessment of immediate release generic formulations should a priori be defined." Although a most effective and durable target saturation is the primary objective for dose development of TKI drugs, it is obvious that for several TKI drugs the recommended dose is the same as the . . .
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