What can Regulatory Bodies require ?1. Preclinical data

• Knowing the microorganisms:

  • Recent, local sensibility data
    • MIC distributions
    • population analysis

• Knowing the intrinsic properties of the drug

  • PK / PD parameters associated with
    • efficacy
    • resistance
    • toxicity

Where are the MIC50, 90, 99 ?

Subpopulations of R+ org. ?

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