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T.Mazzei, A.Novelli pdf - Sipps

T.Mazzei, A.Novelli pdf - Sipps

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• There are arguments suggesting all generic antibiotic drugs do not<br />

present the full reliability needed to claim therapeutic equivalence with<br />

branded drugs<br />

• There are differences at all levels: drug components, levels of impurity,<br />

pharmacokinetics, PK/PD relationship, in vitro effectiveness,<br />

therapeutic effectiveness in experimental models, etc.<br />

• Even if most of this information needs to be verified, it seems necessary<br />

to review regulations for marketing authorization of generic antibiotic<br />

drugs

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