标题
The evolution of the regulatory framework for antibacterial agents
作者
关键词
-
出版物
Annals of the New York Academy of Sciences
Volume 1323, Issue 1, Pages 11-21
出版商
Wiley
发表日期
2014-05-03
DOI
10.1111/nyas.12441
参考文献
相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。- 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
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