US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer-Reference-Cited by-同舟云学术

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

Published:2023-08-28 Issue:11 Volume:12 Page:1573-1576
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Shord Stacy S.¹^ORCID,Zhu Hao²,Liu Jiang²,Rahman Atiqur¹,Booth Brian³,Zineh Issam⁴

Affiliation:

1. Division of Cancer Pharmacology II (DCPII), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Silver Spring Maryland USA

2. Division of Pharmacometrics (DPM), OCP, OTS, CDER FDA Silver Spring Maryland USA

3. Division of Cancer Pharmacology I (DCPI), OCP, OTS, CDER FDA Silver Spring Maryland USA

4. OCP, OTS, CDER FDA Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.13033

Reference13 articles.

1. U.S. Food and Drug Administration.Project Optimus. Accessed May 26 2023.https://www.fda.gov/about‐fda/oncology‐center‐excellence/project‐optimus

2. Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks.

3. U.S. Food and Drug Administration.Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases Draft Guidance for Industry. Accessed May 26 2023.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/optimizing‐dosage‐human‐prescription‐drugs‐and‐biological‐products‐treatment‐oncologic‐diseases

4. The Drug-Dosing Conundrum in Oncology — When Less Is More

5. Controlled backfill in oncology dose-finding trials

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1. Role of pharmacometrics and systems pharmacology in facilitating efficient dose optimization in oncology;CPT: Pharmacometrics & Systems Pharmacology;2023-11