Lessons from the fatal french study BIA-10-2474

BMJ (Online)

Volumn 353, Issue , 2016, Pages

  Moore, Nicholas ^a  

^a UNIVERSITÉ DE BORDEAUX   (France)

Author keywords

[No Author keywords available]

Indexed keywords

3 [1 [CYCLOHEXYL(METHYL)CARBAMOYL] 1H IMIDAZOL 4 YL]PYRIDINE 1 OXIDE; FATTY ACID AMIDASE; AMIDASE; AMINE OXIDE; FATTY-ACID AMIDE HYDROLASE; PYRIDINE DERIVATIVE;

DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG SAFETY; DRUG TARGETING; EDITORIAL; FOOD DRUG INTERACTION; FRANCE; HUMAN; NEUROLOGIC DISEASE; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; DRUG RESEARCH; ETHICS; NORMAL HUMAN;

AMIDOHYDROLASES; CLINICAL TRIALS, PHASE I AS TOPIC; CYCLIC N-OXIDES; FRANCE; HEALTHY VOLUNTEERS; HUMANS; NERVOUS SYSTEM DISEASES; PHARMACEUTICAL RESEARCH; PYRIDINES;

EID: 84969988921     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i2727     Document Type: Editorial

References (4)

1. Hawkes N. Details of French trial must be released urgently, say UK experts. BMJ 2016;352:i319. doi:10.1136/bmj.i319 pmid:26783189.
2. Hawkes N. French drug trial had three major failings, says initial report. BMJ 2016;352:i784. doi:10.1136/bmj.i784 pmid:26856616.
3. Temporary Specialist Scientific Committee. Report by the Temporary Specialist 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. http://ansm.sante.fr/content/ download/88057/1108293/version/1/file/CSST-FAAH-Rapport-Final-Version-Anglaise- 18-04-2016.pdf.
4. Moore N. Assessing drug safety. BMJ 2005;330:539-40. doi:10.1136/bmj.330.7490.539-b pmid:15746143.