参考文献: Attarwala H. TGN1412: From Discovery to Disaster. J Young Pharm. 2010 Jul;2(3):332-6. doi: 10.4103/0975-1483.66810. PMID: 21042496; PMCID: PMC2964774. Horvath C, Andrews L, Baumann A, Black L, Blanset D, Cavagnaro J, Hastings KL, Hutto DL, MacLachlan TK, Milton M, Rey...
Ultimate basis of the TGN1412 disasterDuncan D Adams
“microdoses” are used. Phase 0 as it applies to oncology is discussed below. Critics would quote the TGN1412 disaster and also point out some less well-described instances where even seemingly “benign” drugs such as erlotinib did not result in any life-threatening toxicities, but did ...
The author re-examines the Northwick Park disaster from this standpoint and demonstrates how the Brent Medical Ethics Committee's review of the TGN1412 protocol followed the operational guidance handed down to them and failed to protect the trial subjects as a consequence. The guidance has not ...
The author re-examines the Northwick Park disaster from this standpoint and demonstrates how the Brent Medical Ethics Committee's review of the TGN1412 protocol followed the operational guidance handed down to them and failed to protect the trial subjects as a consequence. The guidance has not ...
[6]Attarwala H. TGN1412: From Discovery toDisaster[J]. Journal of Young Pharmacists Jyp, 2010, 2(3):332. [7]ANSM.Report by the Temporary SpecialistScientific Committee(TSSC),"FAAH(Fatty Acid Amide Hydrolase)",on the Causes of The Accident during Phase1Clinical Trial[EB/OL].(2016-04-25...
TGN1412 - Did the striking nutritional contrasts between the rats and men contribute to the disaster?Michael A. Crawford
The failure of regulatory science to keep pace with and support the development of new biological medicines was very publically highlighted in March 2006 when the first-in-man Phase I clinical trial of the immunomodulatory CD28-specific monoclonal antibody (mAb) TGN1412 ended in disaster when all ...
The failure of regulatory science to keep pace with and support the development of new biological medicines was very publically highlighted in March 2006 when the first-in-man Phase I clinical trial of the immunomodulatory CD28-specific monoclonal antibody (mAb) TGN1412 ended in disaster when all ...
In 2006, a first-in-man phase-I clinical trial of an immunomodulatory mAb, TGN1412, ended in disaster when six healthy recipients suffered a life-threatening systemic inflammatory response, termed a 'Cytokine Storm'. A subsequent investigation concluded that these serious adverse events, not ...