An Industry Perspective on the 2017 EMA Guideline on First‐in‐Human and Early Clinical Trials-Reference-Cited by-同舟云学术

An Industry Perspective on the 2017 EMA Guideline on First‐in‐Human and Early Clinical Trials

Published:2017-12-29 Issue:4 Volume:103 Page:566-569
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

DeGeorge Joseph¹,Robertson Sarah²,Butler Lynne³,Derzi Mazin³,Stoch S. Aubrey⁴,Diaz Dolores⁵,Hartke James⁶,Guzzie‐Peck Peggy⁷,Mortimer‐Cassen Elisabeth⁸,Bogdanffy Matthew⁹,Will Yvonne³,Greene Nigel¹⁰

Affiliation:

1. Bianca HoldingsLansdale Pennsylvania USA

2. Vertex PharmaceuticalsBoston Massachusetts USA

3. Pfizer Worldwide Research and DevelopmentGroton Connecticut USA

4. Merck & Co, Inc.Kenilworth New Jersey USA

5. Denali TherapeuticsSan Francisco California USA

6. Celgene, Nonclinical DevelopmentSan Diego California USA

7. Janssen Research and DevelopmentSpring House Pennsylvania USA

8. AstraZenecaMelbourne Hertfordshire UK

9. Boehringer Ingelheim PharmaceuticalsRidgefield CT USA

10. AstraZenecaWaltham Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.984

Reference8 articles.

1. Implications of the BIA-102474-101 study for review of first-into-human clinical trials

2. Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase

3. Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective

4. Risks of phase I research with healthy participants: A systematic review

5. First-in-Human Clinical Trials — What We Can Learn from Tragic Failures

Cited by 2 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. Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL‐17A (LY3509754): A Phase I Randomized Placebo‐Controlled Study;Clinical Pharmacology & Therapeutics;2024-01-31

2. The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials;Clinical Pharmacology & Therapeutics;2018-07-14