author-photo

David E. Martin

Center for Drug Evaluation and Research

18

Papers

729

Citations

Citation Trend

Filter By

Papers (18) Sort By

Journal Conference Others

Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting.

2020 Therapeutic Innovation & Regulatory Science
Show All
- Source
- Cite
- Save
Citations (5)
Validation of febrile seizures identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program

2019 Vaccine
Show All
- Source
- Cite
- Save
Citations (1)
Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making

2019 Clinical Pharmacology & Therapeutics
Show All
- Source
- Cite
- Save
Citations (59)
Nonrandomized real‐world evidence to support regulatory decision‐making: Process for a randomized trial replication project

2019 Clinical Pharmacology & Therapeutics
Show All
- Source
- Cite
- Save
Citations (35)
Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial – Cardiovascular Safety of Linagliptin vs. Glimepiride

2019 Diabetes Care
Show All
- Source
- Cite
- Save
Citations (44)
Sequential surveillance for drug safety in a regulatory environment

2018 Pharmacoepidemiology and Drug Safety
Show All
- Source
- Cite
- Save
Citations (7)
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision‐Making

2016 Clinical Pharmacology & Therapeutics
Show All
- Source
- Cite
- Save
Citations (31)
Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug–outcome association

2016 Pharmacoepidemiology and Drug Safety
Show All
- Source
- Cite
- Save
Citations (20)
Pharmacokinetics and Pharmacodynamics of TBR-652, a Novel CCR5 Antagonist, in HIV-1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients

2011 Antimicrobial Agents and Chemotherapy
Show All
- Source
- Cite
- Save
Citations (36)
Safety, Efficacy, and Pharmacokinetics of TBR-652, a CCR5/CCR2 Antagonist, in HIV-1―Infected, Treatment-Experienced, CCR5 Antagonist―Naive Subjects

2011 Journal of Acquired Immune Deficiency Syndromes
Show All
- Source
- Cite
- Save
Citations (59)