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Antimicrobial Resistance Solutions
Antimicrobial Chemotherapy Conference 2019
Clinical Microbiology for a Development Program
European Commission: Funding opportunities
Target product profiles for needed antibacterial agents: enteric fever, gonorrhoea, neonatal sepsis, urinary tract infections and meeting report
European Committee on Antimicrobial Susceptibility Testing – EUCAST
Clinical & Laboratory Standards Institute: CLSI Guidelines
Tackling the drug-resistance pandemic – 2020 and beyond
Running a phase 3 trial for a new drug for gonorrhoea during the coronavirus pandemic
Why we need to prioritize developing antibiotics for children
A new cephalosporin has been approved
Journey towards a better antimicrobial pipeline; is there light at the end of the tunnel?
Recent approvals – do they make a difference?
Developing antibiotics for children – medical need and regulatory challenges
Building better breakpoints: data and methods needed to determine breakpoints for new agents
Putting children first in the fight against antibiotic resistance
GARDP: Bringing new treatments for drug-resistant infections to all who need them
Non-traditional antibacterial therapeutic options and challenges
Clinical development for non-developers Part 3: Antibacterial Drug Enhancer Combinations and Non-traditional Products
Clinical development for non-developers, part 2: Development of antibacterial drugs targeting specific pathogens
PK-PD in support of accelerated programmes for antimicrobial development: how much is enough?
Antibacterial drugs: Clinical development for non-developers Part 1: Traditional development – tiers A and B
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
Therapeutic window
Target product profile (TPP)
Standard of care (SOC)
Sepsis
Randomized clinical trial (RCT)
Pro-drug
Placebo-controlled trial
Non-inferiority margin
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)