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Antimicrobial Resistance Solutions
Bootcamp: Post-Approval Economics for New Antibiotics (ASM/ESCMID 2019)
European Committee on Antimicrobial Susceptibility Testing – EUCAST
Clinical & Laboratory Standards Institute: CLSI Guidelines
The antibiotics marketplace collapse: It’s just math, and it’s a solvable equation’
Developing antibiotics for children – medical need and regulatory challenges
Putting children first in the fight against antibiotic resistance
Adaptive trial
Phase 1, 2, 3, 4 trials
Clinical Development
Minimum inhibitory concentration (MIC)
Investigational new drug (IND)
Breakpoint concentration, clinical
Pharmacokinetics-pharmacodynamics (PK/PD)
Superiority trial
Plasma concentration
Antiseptic
Therapeutic window
Standard of care (SOC)
Sepsis
Randomized clinical trial (RCT)
Pro-drug
Pharmacovigilance
Drug product, medicinal product
Cmax
Antimicrobial susceptibility testing (AST), resistance testing
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Marketing authorization application (MAA)
Limited population pathway for antimicrobial and antifungal drugs (LPAD)
Non-inferiority trial
Active pharmaceutical ingredient (API)