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Table 1 Basic scientific requirements for a fixed-dose combination [8]

From: Not recommended fixed-dose antibiotic combinations in low- and middle-income countries – the example of Tanzania

1. Justification of the pharmacological and medical rationale for the combination

2. Establishment of the evidence base for the:

 a. relevant contribution of all active substances to the desired therapeutic effect (efficacy and/or safety)

 b. positive benefit-risk for the combination in the targeted indication

3.  Demonstration that the evidence presented is relevant to the fixed combination medicinal product for which the application is made

  1. Adapted from: EMA. Guideline on clinical development of fixed combination medicinal products 2017 (8)
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Antimicrobial Resistance & Infection Control

ISSN: 2047-2994

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