Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective-Reference-Cited by-同舟云学术

Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

Published:2017-11-06 Issue:4 Volume:103 Page:564-566
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Ponzano Stefano¹,Blake Kevin¹,Bonelli Milton¹,Enzmann Harald²,

Affiliation:

1. European Medicines AgencyLondon UK

2. The Federal Institute for Drugs and Medical Devices (BfArM)Bonn Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.899

Reference6 articles.

1. Procedure for European Union Guideline and Related Documents within the Pharmaceutical Legislative Framework (EMEA/P/24143/2004 Rev. 1 corr.). European Medicines Agency London.2009.

2. Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412

3. Strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products. (2017).

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

5. International Council for Harmonisation (ICH) Safety Guidelines (2017).

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