Cynthia J Girman (Cynthia Girman)

Publication Activity (10 Years)

Years Active: 2018-2024
Publications (10 Years): 9

Top Topics

Ankylosing Spondylitis

Systemic Sclerosis

Electronic Health Record

Drug Administration

Top Venues

Pharmacoepidemiology and drug safety

Therapeutic innovation & regulatory science

This page only lists publications with an associated author ORCID identifier.

Publications

Jessica C Young, Michael A Webster-Clark, Shahar Shmuel, Elizabeth M Garry, Panagiotis Mavros, Til Stürmer, Cynthia J Girman
Clarifying the causal contrast: An empirical example applying the prevalent new user study design. Pharmacoepidemiology and drug safety 33 (4) (2024)
Soulmaz Fazeli Farsani, Kristy Iglay, Ling Zhang, Christian Niyonkuru, Laurieann Nessralla, Cynthia J Girman
Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post-authorization safety study. Pharmacoepidemiology and drug safety 33 (5) (2024)
Soulmaz Fazeli Farsani, Kristy Iglay, Ling Zhang, Christian Niyonkuru, Laurieann Nessralla, Cynthia J Girman
Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post-authorization safety study. Pharmacoepidemiology and drug safety 33 (5) (2024)
Cathy Anne Pinto, Tommi Tervonen, Aura Cecilia Jimenez-Moreno, Bennett Levitan, Montse Soriano Gabarró, Cynthia J Girman, Josephine M Norquist, A Brett Hauber
Current Practices and Challenges When Submitting Patient Experience Data for Regulatory Decisions by the US Food and Drug Administration: An Industry Survey. The patient (2023)
Xinruo Zhang, Katherine Brind'Amour, Kelly E King, Susan Hartmaier, Katherine Harris, David A Weinstein, Cynthia J Girman
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video. Therapeutic innovation & regulatory science (2023)
Michael A Webster-Clark, Panagiotis Mavros, Elizabeth M Garry, Til Stürmer, Shahar Shmuel, Jessica C Young, Cynthia J Girman
Alternative analytic and matching approaches for the prevalent new-user design: A simulation study. Pharmacoepidemiology and drug safety 31 (7) (2022)
Cynthia J Girman, Mary E Ritchey, Vincent Lo Re
Real-world data: Assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products. Pharmacoepidemiology and drug safety 31 (7) (2022)
Cynthia J Girman, Mary E Ritchey, Ann Marie McNeill, Karolina Andersson Sundell, Robert J Meyer
Demonstrating that Real World Evidence Is Fit-For-Purpose to Support Labeling: Parallels to Patient Reported Outcomes in the Pursuit of Labeling Claims. Therapeutic innovation & regulatory science 55 (3) (2021)
Cynthia J Girman, Mary E Ritchey, Wei Zhou, Nancy A Dreyer
Considerations in characterizing real-world data relevance and quality for regulatory purposes: A commentary. Pharmacoepidemiology and drug safety 28 (4) (2018)