Detalles de la búsqueda
1.
Regulatory-grade clinical trial design using real-world data.
Clin Trials
; 17(4): 377-382, 2020 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-32063037
2.
When can real-world data generate real-world evidence?
Pharmacoepidemiol Drug Saf
; 33(1): e5715, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-37855046
3.
The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.
J Asthma
; 55(8): 907-914, 2018 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-28910559
4.
Important statistical considerations in the evaluation of post-market studies to assess whether opioids with abuse-deterrent properties result in reduced abuse in the community.
Pharmacoepidemiol Drug Saf
; 27(5): 473-478, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28833803
5.
Changing patterns of asthma medication use related to US Food and Drug Administration long-acting ß2-agonist regulation from 2005-2011.
J Allergy Clin Immunol
; 137(3): 710-7, 2016 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-26725997
6.
Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation.
Circulation
; 131(2): 157-64, 2015 Jan 13.
Artículo
en Inglés
| MEDLINE | ID: mdl-25359164
7.
Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database.
Pharmacoepidemiol Drug Saf
; 25(9): 1023-32, 2016 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-27146123
8.
Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association.
Pharmacoepidemiol Drug Saf
; 25(9): 973-81, 2016 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-27418432
9.
The role of quantitative safety evaluation in regulatory decision making of drugs.
J Biopharm Stat
; 26(1): 17-29, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-26372792
10.
University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records in randomized clinical trials-challenges and opportunities (morning panel session).
Clin Trials
; 17(4): 405-413, 2020 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-32615793
11.
Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products.
JAMA
; 314(19): 2062-8, 2015 Nov 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-26575062
12.
Risk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers - a cohort study using the Clinical Practice Research Datalink.
Pharmacoepidemiol Drug Saf
; 23(4): 340-7, 2014 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-24285502
13.
Cardiovascular and mortality risk in elderly Medicare beneficiaries treated with olmesartan versus other angiotensin receptor blockers.
Pharmacoepidemiol Drug Saf
; 23(4): 331-9, 2014 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-24277678
14.
Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study.
Pharmacoepidemiol Drug Saf
; 23(11): 1205-12, 2014 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-25044169
15.
Round window reinforcement for superior semicircular canal dehiscence: a retrospective multi-center case series.
Am J Otolaryngol
; 35(3): 286-93, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-24667055
16.
Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone.
Mov Disord
; 28(4): 490-7, 2013 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-23443994
17.
Use of selective serotonin reuptake inhibitors in pregnancy and cardiac malformations: a propensity-score matched cohort in CPRD.
Pharmacoepidemiol Drug Saf
; 22(9): 942-51, 2013 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-23733623
18.
Multivariable confounding adjustment in distributed data networks without sharing of patient-level data.
Pharmacoepidemiol Drug Saf
; 22(11): 1171-7, 2013 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-23878013
19.
Regulatory issues of propensity score methodology application to drug and device safety studies.
J Biopharm Stat
; 23(1): 110-21, 2013.
Artículo
en Inglés
| MEDLINE | ID: mdl-23331225
20.
Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.
JAMA Netw Open
; 5(5): e2214321, 2022 05 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-35639381