Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects-Reference-Cited by-同舟云学术

Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects

Published:2018-05-15 Issue:7 Volume:84 Page:1457-1466
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

van Gerven Joop¹^ORCID,Cohen Adam²^ORCID

Affiliation:

1. Central Commission for Human Research (CCMO); Den Haag The Netherlands

2. Centre for Human Drug Research; Leiden The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.13529/fullpdf

Reference14 articles.

1. Acute neurologic disorder from an inhibitor of fatty acid amide hydrolase;Kerbrat;N Engl J Med,2016

2. Establishing risk of human experimentation with drugs: lessons from TGN1412;Kenter;Lancet,2006

3. Effective visualization of integrated knowledge and data to enable informed decisions in drug development and translational medicine;Brynne;J Transl Med,2013

4. Developing drug prototypes: pharmacology replaces safety and tolerability?;Cohen;Nat Rev Drug Discov,2010

5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for good clinical practice E6 1996 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Cited by 17 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. Preclinical assessment for translation to humans: The PATH approach for assessing supporting evidence for early-phase trials and innovative care;Med;2024-08

2. Principles of performing pediatric clinical drug trials;Essentials of Translational Pediatric Drug Development;2024

3. Anxiolytic effects of endocannabinoid enhancing compounds: A systematic review and meta-analysis;European Neuropsychopharmacology;2023-07

4. Translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system active drugs;Translational Psychiatry;2023-03-01

5. Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration–effect relations using the IB-de-risk tool;Journal of Psychopharmacology;2022-10-14