Design and Conduct Considerations for First-in-Human Trials-Reference-Cited by-同舟云学术

Design and Conduct Considerations for First-in-Human Trials

Published:2018-08-24 Issue:1 Volume:12 Page:6-19
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Shen Jie¹,Swift Brandon²,Mamelok Richard³,Pine Samuel⁴,Sinclair John⁵,Attar Mayssa⁶

Affiliation:

1. Clinical Pharmacology; Allergan California USA

2. Clinical Pharmacology; Roivant Sciences; Durham North Carolina USA

3. Mamelok Consulting; Palo Alto California USA

4. Bioanalytical Operations; BioAgilytix; Hamburg Germany

5. Nonclinical Development; Kodiak Sciences Inc.; Palo Alto California USA

6. Non-Clinical and Translational Sciences; Allergan California USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/cts.12582/fullpdf

Reference65 articles.

1. Food and Drug Administration, Center for Drug Evaluation and Research Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers https://www.fda.gov/downloads/drugs/guidances/ucm078932.pdf 2005

2. European Medicines Agency Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001001.jsp&mid=WC0b01ac0580029570 2018

3. Faqi , A. S. A Comprehensive Guide to Toxicology in Preclinical Drug Development Academic Press London 2013 885

4. Gad , S. C Safety Evaluation of Pharmaceuticals and Medical Devices Springer US Boston, MA 2011

5. Current nonclinical testing paradigms in support of safe clinical trials: an IQ Consortium DruSafe perspective;Butler;Regul. Toxicol. Pharmacol.,2017

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