Publications by authors named "Simone Pinheiro"

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Developing and Refining the Pregnancy Algorithm CErtaInty Tool (ACE-IT) for Validating Pregnancy Outcomes.
Sonal Singh, Hsiao-Ching Huang, Susan E Andrade, Lesley Butler, Sangmi Kim, Simone Pinheiro

Clin Pharmacol Ther· January 2026

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Emulations of oncology trials using real-world data: a systematic literature review.
Jennifer R Rider, Asher Wasserman, Lukas Slipski, Gillis Carrigan, Raymond Harvey, Simone Pinheiro

Am J Epidemiol· June 2025

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Calibrating Observational Health Record Data Against a Randomized Trial.
David Merola, Ulka Campbell, David Lenis, Sebastian Schneeweiss, Shirley Wang, Simone Pinheiro

JAMA Netw Open· September 2024

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Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry.
Vicki Osborne, Amie Goodin, Joshua Brown, Almut G Winterstein, Andrew Bate, Simone Pinheiro

Pharmacoepidemiol Drug Saf· April 2024

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The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology.
David Merola, Ulka Campbell, Nileesa Gautam, Alexa Rubens, Sebastian Schneeweiss, Simone Pinheiro

Clin Pharmacol Ther· June 2023

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HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
Shirley V Wang, Anton Pottegård, William Crown, Peter Arlett, Darren M Ashcroft, Simone Pinheiro

Pharmacoepidemiol Drug Saf· January 2023

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HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force.
Shirley V Wang, Anton Pottegård, William Crown, Peter Arlett, Darren M Ashcroft, Simone Pinheiro

Value Health· October 2022

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STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies.
Shirley V Wang, Simone Pinheiro, Wei Hua, Peter Arlett, Yoshiaki Uyama

BMJ· January 2021

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Entacapone and prostate cancer in Parkinson's disease patients: A large Veterans Affairs healthcare system study.
Jacqueline M Major, Diane Dong, Francesca Cunningham, Kunthel By, Kwan Hur, Simone Pinheiro

Parkinsonism Relat Disord· August 2018

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The Effect of FDA Drug Safety Communications on Patterns of Tiotropium Dispensing: A U.S. Health Plan Claims Database Study.
Jacqueline M Major, Esther H Zhou, Yulan Ding, Thomas Ly, Jie Li, Simone P Pinheiro

J Manag Care Spec Pharm· July 2018

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Research Directions in Genetic Predispositions to Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis.
Teri A Manolio, Carolyn M Hutter, Mark Avigan, Ricardo Cibotti, Robert L Davis, Simone Pinheiro

Clin Pharmacol Ther· March 2018

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Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.
Simone P Pinheiro, Donna R Rivera, David J Graham, Andrew N Freedman, Jacqueline M Major

Ann Epidemiol· November 2016

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Strategies addressing inadequate information on health factors in pharmacoepidemiology studies relying on healthcare databases: commentary from a public workshop.
Efe Eworuke, Fadia Shaya, David J Graham, Jacqueline Major, Mark Levenson, Simone Pinheiro

Pharmacoepidemiol Drug Saf· September 2016

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Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association.
Susan Gruber, Aloka Chakravarty, Susan R Heckbert, Mark Levenson, David Martin, Simone Pinheiro

Pharmacoepidemiol Drug Saf· September 2016

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A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data.
Jennifer C Nelson, Robert Wellman, Onchee Yu, Andrea J Cook, Judith C Maro, Simone Pinheiro

EGEMS (Wash DC)· September 2016

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Use of Prescription Drug Samples in the USA: A Descriptive Study with Considerations for Pharmacoepidemiology.
Christian Hampp, Patty Greene, Simone P Pinheiro

Drug Saf· March 2016

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Identification of Stevens-Johnson syndrome and toxic epidermal necrolysis in electronic health record databases.
Robert L Davis, Mia A Gallagher, Maryam M Asgari, Melody J Eide, David J Margolis, Simone P Pinheiro

Pharmacoepidemiol Drug Saf· July 2015

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Evaluating the validity of clinical codes to identify cataract and glaucoma in the UK Clinical Practice Research Datalink.
Elizabeth M Kang, Simone P Pinheiro, Tarek A Hammad, Adel Abou-Ali

Pharmacoepidemiol Drug Saf· January 2015

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Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems.
Carlos Bell, Aloka Chakravarty, Susan Gruber, Susan R Heckbert, Mark Levenson, Simone Pinheiro

Pharmacoepidemiol Drug Saf· November 2014

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Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.
Tarek A Hammad, George A Neyarapally, Simone P Pinheiro, Solomon Iyasu, George Rochester

Clin Trials· January 2014

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Cardiac safety concerns remain for citalopram at dosages above 40 mg/day.
Steven T Bird, Victor Crentsil, Robert Temple, Simone Pinheiro, Dorothy Demczar

Am J Psychiatry· January 2014

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Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States.
Simone P Pinheiro, Elizabeth M Kang, Clara Y Kim, Laura A Governale, Esther H Zhou

Pharmacoepidemiol Drug Saf· December 2013

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Off-label topical calcineurin inhibitor use in children.
Angelika D Manthripragada, Simone P Pinheiro, Thomas E MaCurdy, Shahin Saneinejad, Chris M Worrall

Pediatrics· November 2013

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Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone.
David J Graham, James R Williams, Ya-Hui Hsueh, Katlyn Calia, Mark Levenson, Simone P Pinheiro

Mov Disord· April 2013

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