Detalhe da pesquisa
1.
U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.
Ann Intern Med
; 174(11): 1603-1611, 2021 11.
Artigo
Inglês
| MEDLINE | ID: mdl-34543584
2.
Discussion of "target estimands for population-adjusted indirect comparisons" by Antonio Remiro-Azocar.
Stat Med
; 41(28): 5573-5576, 2022 12 10.
Artigo
Inglês
| MEDLINE | ID: mdl-36385478
3.
Checking distributional assumptions for pharmacokinetic summary statistics based on simulations with compartmental models.
J Biopharm Stat
; 27(5): 756-772, 2017.
Artigo
Inglês
| MEDLINE | ID: mdl-27669105
4.
Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance.
J Biopharm Stat
; 27(6): 990-1008, 2017.
Artigo
Inglês
| MEDLINE | ID: mdl-28346083
5.
Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials.
Clin Trials
; 13(4): 456-8, 2016 08.
Artigo
Inglês
| MEDLINE | ID: mdl-26908545
6.
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: III. The 2014 Biomarker Working Group Report.
Biol Blood Marrow Transplant
; 21(5): 780-92, 2015 May.
Artigo
Inglês
| MEDLINE | ID: mdl-25644957
7.
Quantifying the impact of time-varying baseline risk adjustment in the self-controlled risk interval design.
Pharmacoepidemiol Drug Saf
; 24(12): 1304-12, 2015 Dec.
Artigo
Inglês
| MEDLINE | ID: mdl-26464236
8.
Letter to the editor by the authors of Exact Calculation of Power and Sample Size in Bioequivalence Studies Using Two One-sided Tests, Pharmaceutical Statistics, DOI: 10.1002/pst.1666.
Pharm Stat
; 14(3): 272, 2015.
Artigo
Inglês
| MEDLINE | ID: mdl-25807931
9.
Exact calculation of power and sample size in bioequivalence studies using two one-sided tests.
Pharm Stat
; 14(2): 95-101, 2015.
Artigo
Inglês
| MEDLINE | ID: mdl-25477145
10.
Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice.
Transfusion
; 54(3): 569-76, 2014 Mar.
Artigo
Inglês
| MEDLINE | ID: mdl-23808572
11.
Multiple in silico tools predict phenotypic manifestations in congenital thrombotic thrombocytopenic purpura.
Br J Haematol
; 160(6): 825-37, 2013 Mar.
Artigo
Inglês
| MEDLINE | ID: mdl-23346910
12.
Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel.
J Infect Dis
; 205 Suppl 2: S209-15, 2012 May 15.
Artigo
Inglês
| MEDLINE | ID: mdl-22476719
13.
Bayesian Strategies in Rare Diseases.
Ther Innov Regul Sci
; 57(3): 445-452, 2023 05.
Artigo
Inglês
| MEDLINE | ID: mdl-36566312
14.
A Tutorial on Modern Bayesian Methods in Clinical Trials.
Ther Innov Regul Sci
; 57(3): 402-416, 2023 05.
Artigo
Inglês
| MEDLINE | ID: mdl-37081374
15.
Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.
Contemp Clin Trials
; 132: 107292, 2023 09.
Artigo
Inglês
| MEDLINE | ID: mdl-37454729
16.
Totality of evidence of the effectiveness of repurposed therapies for COVID-19: Can we use real-world studies alongside randomized controlled trials?
Clin Transl Sci
; 16(10): 1842-1855, 2023 10.
Artigo
Inglês
| MEDLINE | ID: mdl-37466279
17.
FDA perspectives on diagnostic device clinical studies for respiratory infections.
Clin Infect Dis
; 52 Suppl 4: S305-11, 2011 May.
Artigo
Inglês
| MEDLINE | ID: mdl-21460289
18.
A US Food and Drug Administration perspective on evaluating medical products for Ebola.
Clin Trials
; 13(1): 105-9, 2016 Feb.
Artigo
Inglês
| MEDLINE | ID: mdl-26768565
19.
Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches.
Ther Innov Regul Sci
; 55(4): 866-871, 2021 07.
Artigo
Inglês
| MEDLINE | ID: mdl-33886112
20.
Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.
Ther Innov Regul Sci
; 52(2): 187-198, 2018 03.
Artigo
Inglês
| MEDLINE | ID: mdl-29714524