G. Ball

发表

Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Susan P Duke, Susan P. Duke, Jonathan H Seltzer, 2019, Therapeutic Innovation & Regulatory Science.

The importance of cross‐disciplinary scientific engagement in the development of quantitative procedures for aggregate safety assessments

F. Lievano, G. Ball, 2019, Pharmaceutical statistics.

Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 2: Statistical considerations.

G. Ball, L. Piller, 2011, Contemporary clinical trials.

Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Brenda J. Crowe, G. Ball, S. Shahin, 2020, Statistics in biopharmaceutical research.

A phase 2, randomized, double-blind, placebo-controlled trial of clinical activity and safety of subcutaneous A6 in women with asymptomatic CA125 progression after first-line chemotherapy of epithelial ovarian cancer.

K. Behbakht, G. Ball, W. Huh, 2008, Gynecologic oncology.

Statistical Practices of Safety Monitoring: An Industry Survey

Susan P Duke, Susan P. Duke, G. Ball, 2019, Therapeutic innovation & regulatory science.

Meta-analysis of blinded and unblinded studies for ongoing aggregate safety monitoring and evaluation.

Li-An Lin, G. Ball, S. Yuan, 2020, Contemporary clinical trials.

A phase 2a randomized, double‐blind, placebo‐controlled, sequential dose‐escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate‐to‐severe psoriasis

K. Papp, G. Ball, J. Krueger, 2015, The British journal of dermatology.

A Framework for Safety Evaluation Throughout the Product Development Life-Cycle

Eric Lewis, Greg Ball, Frank W Rockhold, 2019, Therapeutic Innovation & Regulatory Science.

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

Greg Ball, Barbara A Hendrickson, William Wang, 2021, Therapeutic Innovation & Regulatory Science.

Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus.

E. Ferrannini, V. Fonseca, John P H Wilding, 2013, Journal of diabetes and its complications.

P1331 : Phase 3B studies to assess long-term clinical outcomes in HCV GT1-infected patients treated with ombitasvir/ paritaprevir/ritonavir and dasabuvir with or without ribavirin

G. Ball, T. Podsadecki, N. Shulman, 2015 .

THU0227 Pooled Analysis of Clinical Safety Data for ASP015K, a Novel Jak Inhibitor in Development for Treatment of Autoimmune Diseases

G. Ball, S. Wisseh, T. Zhu, 2013 .

Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 1: Ethical considerations.

G. Ball, L. Piller, M. Silverman, 2011, Contemporary clinical trials.

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

P. Schnell, G. Ball, 2016, Therapeutic innovation & regulatory science.

A phase 2a randomized, double‐blind, placebo‐controlled, sequential dose‐escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate‐to‐severe psoriasis

K. Papp, G. Ball, J. Krueger, 2015, The British journal of dermatology.

Blinded Safety Signal Monitoring for the FDA IND Reporting Final Rule

Greg Ball, Patrick M. Schnell, P. Schnell, 2016 .