Exposure–response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer-Reference-Cited by-同舟云学术

Exposure–response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer

Published:2021-05-18 Issue:7 Volume:14 Page:927-935
ISSN:1751-2433
Container-title:Expert Review of Clinical Pharmacology
language:en
Short-container-title:Expert Review of Clinical Pharmacology

Author:

Fostvedt Luke K.¹,Shaik Naveed²,Martinelli Giovanni³,Wagner Andrew J.⁴,Ruiz-Garcia Ana²⁵

Affiliation:

1. Pfizer Global Product Development, Pfizer Inc., La Jolla, CA, USA

2. Pfizer Oncology, Pfizer Inc., San Diego, CA, USA

3. IRCSS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” – IRST S.r.l., Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy

4. Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

5. PKPD, Metrum Research Group, San Diego, CA, USA

Funder

funded

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17512433.2021.1925538

Reference20 articles.

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2. US Food and Drug Administration. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs — questions and answers (R3). Guidance for industry [Internet]. 2017 [cited 2020 Jun 30]. Available from: https://www.fda.gov/media/71379/download

3. International Conference on Harmonisation. E14 Implementation Working Group, ICH E14 guideline: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Questions & answers (R3) [Internet]. 2015 [cited 2020 Jun 30]. Available from: https://database.ich.org/sites/default/files/E14_Q%26As_R3_Q%26As.pdf,https://database.ich.org/sites/default/files/E14_Q%26As_R3_Concept_Paper.pdf

4. Scientific white paper on concentration-QTc modeling

5. Impact of Phase 1 study design on estimation of QT interval prolongation risk using exposure–response analysis

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