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US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
- Published in:
- 2020
- By:
- Publication type:
- journal article
Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model.
- Published in:
- 2018
- By:
- Publication type:
- journal article
Understanding the life experience of Barth syndrome from the perspective of adults: a qualitative one-on-one interview study.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Effect of 7 vs 14 Days of Antibiotics Among Afebrile Men With Urinary Tract Infection.
- Published in:
- 2021
- By:
- Publication type:
- Letter to the Editor
Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling.
- Published in:
- 2020
- By:
- Publication type:
- Letter
Antibacterial R&D incentives.
- Published in:
- 2011
- By:
- Publication type:
- journal article
A Comparative Assessment of Approvals and Discontinuations of Systemic Antibiotics and Other Therapeutic Areas.
- Published in:
- Healthcare (2227-9032), 2023, v. 11, n. 12, p. 1759, doi. 10.3390/healthcare11121759
- By:
- Publication type:
- Article
Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico.
- Published in:
- Open Forum Infectious Diseases, 2022, v. 9, n. 7, p. 1, doi. 10.1093/ofid/ofac303
- By:
- Publication type:
- Article
Prospective Assessment of Symptoms to Evaluate Asymptomatic SARS-CoV-2 Infections in a Cohort of Health Care Workers.
- Published in:
- Open Forum Infectious Diseases, 2022, v. 9, n. 3, p. 1, doi. 10.1093/ofid/ofac030
- By:
- Publication type:
- Article
Comparison of Rates of Hospitalization Between Single and Dual Virus Detection in a Mexican Cohort of Children and Adults With Influenza-Like Illness.
- Published in:
- Open Forum Infectious Diseases, 2019, v. 6, n. 11, p. N.PAG, doi. 10.1093/ofid/ofz424
- By:
- Publication type:
- Article
2251. Estimating the Need for Novel Gram-Negative Active Antibiotics in US Hospitals.
- Published in:
- Open Forum Infectious Diseases, 2019, v. 6, p. S769, doi. 10.1093/ofid/ofz360.1929
- By:
- Publication type:
- Article
External Validation of Difficult-to-Treat Resistance Prevalence and Mortality Risk in Gram-Negative Bloodstream Infection Using Electronic Health Record Data From 140 US Hospitals.
- Published in:
- Open Forum Infectious Diseases, 2019, v. 6, n. 4, p. N.PAG, doi. 10.1093/ofid/ofz110
- By:
- Publication type:
- Article
Acute Epiglottitis in the Immunocompromised Host: Case Report and Review of the Literature.
- Published in:
- Open Forum Infectious Diseases, 2018, v. 5, n. 3, p. N.PAG, doi. 10.1093/ofid/ofy038
- By:
- Publication type:
- Article
Comparison of clinical characteristics of Zika and dengue symptomatic infections and other acute illnesses of unidentified origin in Mexico.
- Published in:
- PLoS Neglected Tropical Diseases, 2021, v. 15, n. 2, p. 1, doi. 10.1371/journal.pntd.0009133
- By:
- Publication type:
- Article
The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age.
- Published in:
- Influenza & Other Respiratory Viruses, 2024, v. 18, n. 2, p. 1, doi. 10.1111/irv.13236
- By:
- Publication type:
- Article
Correction: Systematic surveillance of patient-reported symptoms of viral respiratory tract infectious Syndromes in diverse populations.
- Published in:
- 2023
- By:
- Publication type:
- Correction Notice
Antimicrobial Drug Resistance, Regulation, and Research.
- Published in:
- Emerging Infectious Diseases, 2006, v. 12, n. 2, p. 183
- By:
- Publication type:
- Article
Appropriate Antimicrobial Prescribing: Approaches that Limit Antibiotic Resistance.
- Published in:
- American Family Physician, 2001, v. 64, n. 6, p. 999
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- Publication type:
- Article
Accelerating innovation in rapid diagnostics and targeted antibacterials.
- Published in:
- Nature Biotechnology, 2015, v. 33, n. 6, p. 589, doi. 10.1038/nbt.3251
- By:
- Publication type:
- Article
A systematic approach for studying the signs and symptoms of fever in adult patients: the fever assessment tool (FAST).
- Published in:
- 2017
- By:
- Publication type:
- journal article
Association Between Caseload Surge and COVID-19 Survival in 558 U.S. Hospitals, March to August 2020.
- Published in:
- 2021
- By:
- Publication type:
- journal article
Perspectives of US Adults on Antimicrobial Trials With Noninferiority Designs.
- Published in:
- JAMA Network Open, 2023, v. 6, n. 5, p. e2316297, doi. 10.1001/jamanetworkopen.2023.16297
- By:
- Publication type:
- Article
Itraconazole versus Fluconazole for Antifungal Prophylaxis.
- Published in:
- 2004
- By:
- Publication type:
- Letter
Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process.
- Published in:
- JAMA Network Open, 2020, p. e205435, doi. 10.1001/jamanetworkopen.2020.5435
- By:
- Publication type:
- Article
Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009.
- Published in:
- Journal of Law, Medicine & Ethics, 2013, v. 41, n. 3, p. 688, doi. 10.1111/jlme.12079
- By:
- Publication type:
- Article
Determining the Infectious Potential of Individuals With Positive Reverse-Transcription Polymerase Chain Reaction Severe Acute Respiratory Syndrome Coronavirus 2 Tests.
- Published in:
- Clinical Infectious Diseases, 2021, v. 73, n. 11, p. e3900, doi. 10.1093/cid/ciaa1819
- By:
- Publication type:
- Article
Scientific Evidence, Regulatory Decision Making, and Incentives for Therapeutics in Infectious Diseases: The Example of Cefiderocol.
- Published in:
- 2021
- By:
- Publication type:
- Editorial
Improving the Evidence for New Interventions in Infectious Diseases: Refocusing on Patients Instead of Pathogens and Direct Evidence for Added Patient Benefits.
- Published in:
- 2021
- By:
- Publication type:
- Editorial
Pharmacoepidemiology of Ceftazidime-Avibactam Use: A Retrospective Cohort Analysis of 210 US Hospitals.
- Published in:
- Clinical Infectious Diseases, 2021, v. 72, n. 4, p. 611, doi. 10.1093/cid/ciaa061
- By:
- Publication type:
- Article
Patient-Reported Outcome Assessments as Endpoints in Studies in Infectious Diseases.
- Published in:
- Clinical Infectious Diseases, 2016, v. 63, p. S52, doi. 10.1093/cid/ciw317
- By:
- Publication type:
- Article
Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.
- Published in:
- Clinical Infectious Diseases, 2016, v. 62, n. 5, p. 603, doi. 10.1093/cid/civ927
- By:
- Publication type:
- Article
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).
- Published in:
- Clinical Infectious Diseases, 2015, v. 61, n. 5, p. 800, doi. 10.1093/cid/civ495
- By:
- Publication type:
- Article
Do Patient Data Really Support the Clinical and Laboratory Standards Institute Recommendation for Lowering Third-Generation Cephalosporin Interpretive Breakpoints?
- Published in:
- Clinical Infectious Diseases, 2013, v. 57, n. 4, p. 624, doi. 10.1093/cid/cit308
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- Publication type:
- Article
EARLY AMBULATION: ITS INFLUENCE ON POSTOPERATIVE COMPLICATIONS AND RETURN TO WORK FOLLOWING HERNIOPLASTY IN A RURAL POPULATION.
- Published in:
- Annals of the New York Academy of Sciences, 1959, v. 73, n. 2, p. 524, doi. 10.1111/j.1749-6632.1959.tb40827.x
- By:
- Publication type:
- Article
Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19.
- Published in:
- Journal of Patient-Reported Outcomes, 2023, v. 7, n. 1, p. 1, doi. 10.1186/s41687-023-00621-8
- By:
- Publication type:
- Article
Quality of life of HIV-negative, previously healthy individuals following cryptococcal meningoencephalitis.
- Published in:
- Scientific Reports, 2021, v. 11, n. 1, p. 1, doi. 10.1038/s41598-021-83176-2
- By:
- Publication type:
- Article
Comparison of the Impact of Zika and Dengue Virus Infection, and Other Acute Illnesses of Unidentified Origin on Cognitive Functions in a Prospective Cohort in Chiapas Mexico.
- Published in:
- Frontiers in Neurology, 2021, v. 11, p. N.PAG, doi. 10.3389/fneur.2021.631801
- By:
- Publication type:
- Article
Early Fungicidal Activity as a Candidate Surrogate Endpoint for All-Cause Mortality in Cryptococcal Meningitis: A Systematic Review of the Evidence.
- Published in:
- PLoS ONE, 2016, v. 11, n. 8, p. 1, doi. 10.1371/journal.pone.0159727
- By:
- Publication type:
- Article
Biomarkers and surrogate endpoints in clinical trials.
- Published in:
- Statistics in Medicine, 2012, v. 31, n. 25, p. 2973, doi. 10.1002/sim.5403
- By:
- Publication type:
- Article
Noninferiority and equivalence trials: deciphering 'similarity' of medical interventions.
- Published in:
- Statistics in Medicine, 2008, v. 27, n. 3, p. 343, doi. 10.1002/sim.3138
- By:
- Publication type:
- Article
Microbiologic Surrogate End Points in Clinical Trials of Infectious Diseases: Example of Acute Otitis Media Trials.
- Published in:
- Pharmacotherapy, 2005, v. 25, p. 109S, doi. 10.1592/phco.2005.25.12part2.109S
- By:
- Publication type:
- Article
A machine learning approach identifies distinct early-symptom cluster phenotypes which correlate with hospitalization, failure to return to activities, and prolonged COVID-19 symptoms.
- Published in:
- PLoS ONE, 2023, v. 17, n. 2, p. 1, doi. 10.1371/journal.pone.0281272
- By:
- Publication type:
- Article
Impact of respiratory syncytial virus disease on quality of life in adults aged ≥50 years: A qualitative patient experience cross‐sectional study.
- Published in:
- Influenza & Other Respiratory Viruses, 2022, v. 16, n. 3, p. 462, doi. 10.1111/irv.12929
- By:
- Publication type:
- Article
Different epidemiological profiles in patients with Zika and dengue infection in Tapachula, Chiapas in Mexico (2016-2018): an observational, prospective cohort study.
- Published in:
- 2021
- By:
- Publication type:
- journal article
Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus<sup>©</sup>) instrument in patients with COVID-19.
- Published in:
- Quality of Life Research, 2023, v. 32, n. 6, p. 1645, doi. 10.1007/s11136-022-03336-3
- By:
- Publication type:
- Article
Immune and behavioral correlates of protection against symptomatic post-vaccination SARS-CoV-2 infection.
- Published in:
- Frontiers in Immunology, 2024, p. 1, doi. 10.3389/fimmu.2024.1287504
- By:
- Publication type:
- Article
The Fight Against Multidrug-Resistant Bacteria.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.
- Published in:
- 2016
- By:
- Publication type:
- journal article