Preprint

Moss RB, Pryor MM, Baillie R, Kudrycki K, Friedrich C, Reed M, Carlo DJ

Brief Report: Higher Fentanyl Exposures Require Higher Doses of Naloxone for Successful Reversals in a Quantitative Systems Pharmacology Model

Preprint from Research Square, 22 Dec 2021

Peer Reviewed Journal Publication

Kapil Gadkar, Christina Friedrich, Vincent Hurez, Maria-Luisa Ruiz, Leslie Dickmann, Mohit Kumar Jolly, Leah Schutt, Jin Jin, Joseph A Ware, Saroja Ramanujan

Quantitative systems pharmacology model-based investigation of adverse gastrointestinal events associated with prolonged treatment with PI3-kinase inhibitors

Published in CPT Pharmacometrics Systems Pharmacology, December 1, 2021

Poster

Rebecca Baillie, Chris Schelling, Richard Ridgewell, Tongli Zhang, Christina Friedrich, Mike Reed

Using Modeling for Dose Recommendations of A Novel Drug for Urea Cycle Disorders

Presented by Acer Therapeutics and Rosa at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) meeting, November 2021

Poster

Renee Meyers, Tongli Zhang, Christina Friedrich, Michael Weis

Surrogate Modeling with Machine Learning for Faster Virtual Patient Cohort Generation in QSP Models.

Presented by Rosa at the American Conference on Pharmacometrics (ACoP), November 2021

Poster

Rebecca Baillie, Chris Schelling, Richard Ridgewell, Tongli Zhang, Christina Friedrich, Mike Reed

Reuse of a published model with fasting data from a novel drug formulation for a rare disorder

Presented by Acer Therapeutics and Rosa at the Population Approach Group in Europe (PAGE) meeting, September 2021

Poster

Vincent Hurez, Krishnakant Dasika, Katherine Kudrycki, Robert Sheehan, Christina Friedrich, Mike Reed, Glenn Gauderat, Audrey Aussy, Loubna Chadli, Florian Chassereau, Sylvain Fouliard, Sandra Hubert, Emiko Desvaux, Perrine Soret, Alexia Blesius, Philippe Moingeon

Development of a systemic lupus erythematosus (SLE) QSP model linking systemic biomarkers to cutaneous clinical score (CLASI) outcomes.

Presented by Servier and Rosa at the Population Approach Group in Europe (PAGE) meeting, September 2021

Abstract

Rebecca Baillie, Chris Schelling, Richard Ridgewell, Tongli Zhang, Christina Friedrich, Mike Reed

Reuse of a published model to support compassionate use of novel drug formulation for a rare disorder

Presented by Acer Therapeutics and Rosa at the American Society of Clinical Oncology (ASCO), June 2021

Peer Reviewed Journal Publication

Jane P. F. Bai, Brian J. Schmidt, Kapil G. Gadkar, Valeriu Damian, Justin C. Earp, Christina Friedrich, Piet H. van der Graaf, Rajanikanth Madabushi, Cynthia J. Musante, Kunal Naik, Mark Rogge, Hao Zhu

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

Published in AAPS Journal, Apr. 30, 2021

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