Detalhe da pesquisa
1.
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions.
Circulation
; 141(10): 843-862, 2020 03 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-31992065
2.
U.S. racial and ethnic participation in global clinical trials by therapeutic areas.
J Clin Pharm Ther
; 46(6): 1576-1581, 2021 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-34544200
3.
Encouragement of subgroup assessment by the FDA.
Pharm Stat
; 20(5): 923-928, 2021 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-34448536
4.
Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation.
Circulation
; 140(17): 1426-1436, 2019 10 22.
Artigo
em Inglês
| MEDLINE | ID: mdl-31634011
5.
Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.
J Nat Prod
; 83(2): 552-562, 2020 02 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-31977211
6.
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Circulation
; 137(9): 961-972, 2018 02 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-29483172
7.
An Appropriate Use of Accelerated Approval - Aducanumab for Alzheimer's Disease.
N Engl J Med
; 385(9): 856-857, 2021 08 26.
Artigo
em Inglês
| MEDLINE | ID: mdl-34320283
8.
FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Clin Trials
; 16(1): 90-97, 2019 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-30445835
9.
Long-term soft tissue outcomes for hydroxyapatite-coated bone-anchored hearing implant surgery.
Eur Arch Otorhinolaryngol
; 276(11): 3067-3072, 2019 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-31451899
10.
Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?
Am Heart J
; 199: 59-67, 2018 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-29754667
11.
Leveraging electronic health records for clinical research.
Am Heart J
; 202: 13-19, 2018 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-29802975
12.
Challenges of developing and conducting clinical trials in rare disorders.
Am J Med Genet A
; 176(4): 773-783, 2018 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-28815894
13.
Esketamine for Treatment-Resistant Depression - First FDA-Approved Antidepressant in a New Class.
N Engl J Med
; 381(1): 1-4, 2019 Jul 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-31116916
14.
Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.
Circulation
; 132(15): 1425-32, 2015 Oct 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-26459078
15.
Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.
Epilepsia
; 56(9): 1415-24, 2015 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-26201987
16.
Stability and survival of bone-anchored hearing aid implant systems in post-irradiated patients.
Eur Arch Otorhinolaryngol
; 272(6): 1371-6, 2015 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-24532083
17.
Remembering Dr Ray Lipicky.
Circulation
; 137(13): 1309, 2018 03 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-29581359
18.
Real-World Evidence - What Is It and What Can It Tell Us?
N Engl J Med
; 375(23): 2293-2297, 2016 Dec 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-27959688
19.
Independent data monitoring committees: preparing a path for the future.
Am Heart J
; 168(2): 135-41.e1, 2014 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-25066551
20.
Stroke prevention in atrial fibrillation: Closing the gap.
Am Heart J
; 210: 29-38, 2019 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-30731371