The Bial 10-2474 Phase 1 Study-A Drug Development Perspective and Recommendations for Future First-in-Human Trials

Author:

Chaikin Philip1

Affiliation:

1. President; Chaikin Associates LLC; Sarasota FL USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference15 articles.

1. Risks of phase I research with healthy participants: a systematic review;Johnson;Clin Trials,2016

2. Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies;Emanuel;BMJ,2015

3. Death but one unintended consequence of gene therapy trial;Sibbald;Can Med Assoc J,2001

4. The death of a volunteer research subject: lessons to be learned;Olgive;Can Med Assoc J,2001

5. Report by the Temporary Scientific Committee (TSSC) FAAH (fatty acid amide hydrolase),” on the causes of the accident during a phase 1 clinical trial in Rennes in January 2016. Saint-Denis, France: AgenceNationale de Securite du Medicament et des Produits de Sante http://ansm.sante.fr/var/ansm_site/storage/original/application/744c7c6daf96b141bc9509e2f85c227e.pdf

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