Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions-Reference-Cited by-同舟云学术

Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

Published:2019-07 Issue:10 Volume:13 Page:805-809
ISSN:1752-0363
Container-title:Biomarkers in Medicine
language:en
Short-container-title:Biomarkers in Medicine

Author:

Wang Yow-Ming C¹,Strauss David G¹,Huang Shiew Mei¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation & Research, Food & Drug Administration, Silver Spring, MD 20993, USA

Publisher

Future Medicine Ltd

Subject

Biochemistry, medical,Clinical Biochemistry,Drug Discovery

Link

https://www.futuremedicine.com/doi/pdf/10.2217/bmm-2019-0197

Reference20 articles.

1. Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

2. Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine

3. Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

4. Multiplex assay for multiomics advances in personalized-precision medicine

5. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource (2016). www.ncbi.nlm.nih.gov/pubmed/27010052

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Biomarker-guided drug development provides value for patients, payers and drug developers: lessons learned from 25 years in the biomarker industry;Biomarkers;2024-04-29

2. Support for Removing Pharmacodynamic and Clinical Efficacy Testing of Biosimilars: A Critical Analysis;Clinical Pharmacology in Drug Development;2023-11-14

3. New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science;Frontiers in Medicine;2023-01-19

4. Pharmacogenomics in Drug Research and Development;Pharmacogenomics in Clinical Practice;2023

5. Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary;Clinical Pharmacology & Therapeutics;2022-12-02