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Evaluation of medicinal products indicated for treatment of bacterial infections

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Article published on the European Medicines Agency on May 19, 2022

This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2) and the Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013).

Keywords: Non-inferiority studies, superiority studies, susceptibility testing, pharmacokinetic / pharmacodynamic (PK/PD) relationship, bacteraemia, febrile neutropenia, eradication of carriage, drug-resistant organisms; paediatric investigation plan (PIP)

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