A. Dane

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Data-Driven and Confirmatory Subgroup Analysis in Clinical Trials

I. Lipkovich, A. Dmitrienko, A. Dane, 2020 .

Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

T. Fleming, J. Powers, A. Torres, 2019, The Journal of infectious diseases.

On k-medoid clustering of large data sets with the aid of a genetic algorithm: background, feasiblity and comparison

C. B. Lucasius, C. Lucasius, G. Kateman, 1993 .

Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE’s STAT-Net

Leonhard Held, Stephan Harbarth, Stavros Nikolakopoulos, 2018, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies

A. Dane, J. Wetherington, 2014, Pharmaceutical statistics.

Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

H. Goossens, V. Fowler, A. McDonnell, 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Progress in the Fight Against Multidrug-Resistant Bacteria 2005–2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance

J. Rex, A. Dane, B. Eisenstein, 2017, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of SPR720, a Novel Oral Bacterial DNA Gyrase (GyrB) Inhibitor for Mycobacterial Infections

A. Dane, D. Melnick, Vipul K. Gupta, 2021, Antimicrobial agents and chemotherapy.

Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial

L. Rice, P. Eckburg, K. Kaye, 2019, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents

G. Drusano, A. Eakin, A. Dane, 2019, Antimicrobial Agents and Chemotherapy.

Pharmacodynamics of Cefepime Combined with the Novel Extended-Spectrum-β-Lactamase (ESBL) Inhibitor Enmetazobactam for Murine Pneumonia Caused by ESBL-Producing Klebsiella pneumoniae

R. Kolamunnage-Dona, G. Drusano, P. Knechtle, 2020, Antimicrobial Agents and Chemotherapy.

Software for Dosage Individualization of Voriconazole: a Prospective Clinical Study

M. Pirmohamed, M. Neely, D. Carr, 2019, Antimicrobial Agents and Chemotherapy.

Addressing the need for new antibacterials--authors' reply.

C. Knirsch, J. Rex, W. Sanhai, 2013, The Lancet. Infectious diseases.

Active controlled studies in antibiotic drug development

A. Dane, 2011, Pharmaceutical statistics.

Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection.

P. Eckburg, A. Dane, I. Critchley, 2022, The New England journal of medicine.

LB-3. Oral Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem in Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) – Results from the Pivotal ADAPT-PO Study

A. Dane, D. Melnick, A. Talley, 2020 .

Safety, Pharmacokinetics, and Food Effect of Tebipenem Pivoxil Hydrobromide after Single and Multiple Ascending Oral Doses in Healthy Adult Subjects

P. Eckburg, A. Dane, D. Melnick, 2019, Antimicrobial Agents and Chemotherapy.

Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS)

L. Rice, P. Eckburg, K. Kaye, 2017 .

Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis

Ilya Lipkovich, Tom Parke, I. Lipkovich, 2018, Pharmaceutical statistics.

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

Wendy R. Sanhai, C. Knirsch, J. Rex, 2013, The Lancet. Infectious diseases.

An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones

T. Louie, J. de Gunzburg, M. Wilcox, 2022, The Journal of antimicrobial chemotherapy.

Pharmacodynamics of Tebipenem: New Options for Oral Treatment of Multidrug-Resistant Gram-Negative Infections

A. Dane, J. Unsworth, P. Ambrose, 2019, Antimicrobial Agents and Chemotherapy.

The Value of the Information That Can Be Generated: Optimizing Study Design to Enable the Study of Treatments Addressing an Unmet Need for Rare Pathogens

N. Stallard, J. Rex, A. Dane, 2022, Open forum infectious diseases.

Models for the analysis of C‐reactive protein in statin trials

A. Dane, H. Southworth, 2009, Pharmaceutical statistics.

An obituary on DAV-132-authors' viewpoint on the current limits of pivotal trials in clinical microbiome research.

M. Vehreschild, L. Biehl, A. Dane, 2023, The Journal of antimicrobial chemotherapy.

Confidence intervals for the difference between independent binomial proportions: comparison using a graphical approach and moving averages

A. Dane, Peter J Laud, 2014, Pharmaceutical statistics.

731. CERTAIN-1: A Phase 3 Study of Cefepime-Taniborbactam Efficacy and Safety in the Treatment of Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP)

A. Dane, G. Moeck, F. Wagenlehner, 2022, Open Forum Infectious Diseases.