Implications of the BIA-102474-101 study for review of first-into-human clinical trials-Reference-Cited by-同舟云学术

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

Published:2016-03-15 Issue:4 Volume:81 Page:582-586
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Eddleston Michael¹²,Cohen Adam F.³,Webb David J.¹

Affiliation:

1. Pharmacology, Toxicology, & Therapeutics, University/BHF Centre for Cardiovascular Science; University of Edinburgh; Edinburgh UK

2. National Poisons Information Service - Edinburgh; Royal Infirmary of Edinburgh; Edinburgh UK

3. Centre for Human Drug Research; Leiden the Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.12920/fullpdf

Reference18 articles.

1. Should we tolerate tolerability as an objective in early drug development?;Cohen;Br J Clin Pharmacol,2007

2. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412;Suntharalingam;N Engl J Med,2006

3. The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development;Milton;Toxicol Pathol,2009

4. Expert Scientific Group on Phase One Clinical Trials Final Report 2006

5. Committee for Medical Products for Human Use (CHMP) Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products 2007

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