The evolution of the regulatory framework for antibacterial agents

Approval and Withdrawal of New Antibiotics and other Antiinfectives in the U.S., 1980–2009

(2015) Kevin Outterson et al.   JOURNAL OF LAW MEDICINE & ETHICS

Background and Rationale for Revised Clinical and Laboratory Standards Institute Interpretive Criteria (Breakpoints) for Enterobacteriaceae andPseudomonas aeruginosa:I. Cephalosporins and Aztreonam

(2013) Michael N. Dudley et al.   CLINICAL INFECTIOUS DISEASES

Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

(2013) A. M. Caliendo et al.   CLINICAL INFECTIOUS DISEASES

10 x '20 Progress--Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America

(2013) H. W. Boucher et al.   CLINICAL INFECTIOUS DISEASES

Investigational Antimicrobial Agents of 2013

(2013) M. J. Pucci et al.   CLINICAL MICROBIOLOGY REVIEWS

A comprehensive regulatory framework to address the unmet need for new antibacterial treatments

(2013) John H Rex et al.   LANCET INFECTIOUS DISEASES

The value of single-pathogen antibacterial agents

(2013) Brad Spellberg et al.   NATURE REVIEWS DRUG DISCOVERY

Preserving Antibiotics, Rationally

(2013) Aidan Hollis et al.   NEW ENGLAND JOURNAL OF MEDICINE

Commentary

(2013) Michael N. Dudley et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

Use of historical control data for assessing treatment effects in clinical trials

(2013) Kert Viele et al.   PHARMACEUTICAL STATISTICS

Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products

(2013) Meg A. Gamalo et al.   PHARMACEUTICAL STATISTICS

Progress on Developing Endpoints for Registrational Clinical Trials of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections: Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health

(2012) George H. Talbot et al.   CLINICAL INFECTIOUS DISEASES

A Paradigm Shift in Drug Development for Treatment of Rare Multidrug-Resistant Gram-Negative Pathogens

(2012) D. Alemayehu et al.   CLINICAL INFECTIOUS DISEASES

White Paper: Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens

(2012)   CLINICAL INFECTIOUS DISEASES

Linezolid in Methicillin-Resistant Staphylococcus aureus Nosocomial Pneumonia: A Randomized, Controlled Study

(2012) R. G. Wunderink et al.   CLINICAL INFECTIOUS DISEASES

Editorial Commentary: Asking the Right Questions: Morbidity, Mortality, and Measuring What's Important in Unbiased Evaluations of Antimicrobials

(2012) J. H. Powers   CLINICAL INFECTIOUS DISEASES

Overcoming the challenges to developing new antibiotics

(2012) David M Shlaes et al.   CURRENT OPINION IN PHARMACOLOGY

The critical impact of time discounting on economic incentives to overcome the antibiotic market failure

(2012) Brad Spellberg et al.   NATURE REVIEWS DRUG DISCOVERY

Frequentist and Bayesian Pharmacometric-Based Approaches To Facilitate Critically Needed New Antibiotic Development: Overcoming Lies, Damn Lies, and Statistics

(2011) Paul G. Ambrose et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Cefazolin and Enterobacteriaceae: Rationale for Revised Susceptibility Testing Breakpoints

(2011) J. D. Turnidge et al.   CLINICAL INFECTIOUS DISEASES

The role of pharmacokinetics/pharmacodynamics in setting clinical MIC breakpoints: the EUCAST approach

(2011) J.W. Mouton et al.   CLINICAL MICROBIOLOGY AND INFECTION

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

(2011) Joo Yeon Lee et al.   CLINICAL PHARMACOKINETICS

Pharmacokinetic‐Pharmacodynamic Considerations in the Design of Hospital‐Acquired or Ventilator‐Associated Bacterial Pneumonia Studies: Look before You Leap!

(2010) Paul G. Ambrose et al.   CLINICAL INFECTIOUS DISEASES

Intravenous Doripenem at 500 Milligrams versus Levofloxacin at 250 Milligrams, with an Option To Switch to Oral Therapy, for Treatment of Complicated Lower Urinary Tract Infection and Pyelonephritis

(2009) K. G. Naber et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: A multicenter, randomized study*

(2009) Jean Chastre et al.   CRITICAL CARE MEDICINE

Use of Pharmacokinetics and Pharmacodynamics in a Failure Analysis of Community‐Acquired Pneumonia: Implications for Future Clinical Trial Study Design

(2008) Paul G. Ambrose   CLINICAL INFECTIOUS DISEASES

Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: A phase III, prospective, multicenter, randomized, double-blind, noninferiority study

(2008) Christopher Lucasti et al.   CLINICAL THERAPEUTICS