A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. (Q38410974)

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22 February 2020

title

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

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1

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author name string

Barry I Eisenstein

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Jeff Alder

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Mark Goldberger

4

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Robert Meyer

5

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Aaron Dane

6

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22 February 2020

Ian Friedland

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22 February 2020

Charles Knirsch

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22 February 2020

Wendy R Sanhai

9

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22 February 2020

John Tomayko

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Cindy Lancaster

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Jennifer Jackson

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22 February 2020

publication date

15 January 2013

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Lancet Infectious Diseases

22 February 2020

published in

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volume

13

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issue

3

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page(s)

269-275

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Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America

22 February 2020

cites work

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Drugs for bad bugs: confronting the challenges of antibacterial discovery

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Understanding the regulatory hurdles for antibacterial drug development in the post‐Ketek world

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Why is big Pharma getting out of antibacterial drug discovery?

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Stoking the antibiotic pipeline.

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

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Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?

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Learning versus confirming in clinical drug development

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Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval

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7 January 2021

Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men.

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Antimicrobial Resistance: Pharmacokinetics‐Pharmacodynamics of Antimicrobial Therapy: It’s Not Just for Mice Anymore

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Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

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Trends in risks associated with new drug development: success rates for investigational drugs

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7 January 2021

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

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7 January 2021

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

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7 January 2021

Treatment of Ventilator‐Associated Pneumonia with Piperacillin‐Tazobactam/Amikacin Versus Ceftazidime/Amikacin: A Multicenter, Randomized Controlled Trial

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7 January 2021

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

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7 January 2021

When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?

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7 January 2021

10.1016/S1473-3099(12)70293-1

Identifiers

DOI

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22 February 2020

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