Vol.34, Suppl �]�]�W 2006　What is the TGN 1412 case ?

contents
●Editorial
Drug development strategy and clinical knowledge	Nakajima A	6
What is the truth of TGN1412 case?	Kurihara M	7
●message
For the special issue on the TGN1412 case	Kurokawa T	9
●Articles Part 1
TGN1412 clinical trial−The truth is still shrouded in mystery−	Saio T	13-22
Learning from the TGN1412 case−Drug regulation fails to protect human subjects−	Kurihara C	23-38
Antibody-drugs in the era without the national drug policy of Japan 　 　−some considerations triggered by the TGN1412 tragedy−	Kamada I	39-47
Learning from the Accident of TGN1412	Yamazaki T, Kasahara T	49-70
The impact of the TGN1412 accident on Japanese regulatory authorities	Mori K	71-80
Safety assessment of antibody therapeutics−Preclinical consideration of TGN1412 case−	Kobayashi K	81-7
TGN1412 and Toxicology Guidelines	Unno T	89-98
Characteristics of nonhuman primates as laboratory animal species	Nomura M	99-104
The TGN1412 tragedy from a toxicologist's point of view	Matsumoto K	105-14
A survey of serious adverse events in clinical pharmacological studies 　 　from 1993 to 2004 in Japan	Kikuchi Y，Iijima H, Monma T，et al.	115-21
●Articles Part 2
Protection of Human Subjects: Lessons learned from the TGN1412 clinical trial	Tsuji J	125-48
Rethinking research ethics from the TGN1412 trial 　 　−Toward a fairer distribution of risks in clinical trials−	Tashiro S	149-62
Thoughts over the TGN1412 case	Kumagai Y	163-9
The crucial negligence of the regulatory authority and the company 　 　−Normal evaluation of the results of animal experimentation could have prevented 　 　　the TGN1412 tragedy−	Hama R	171-84
●Impressions and material
Impressions of the symposium	Kayukawa J	187-8
MABEL（Minimal Anticipated Biological Effect Level）	Pharmacovigilance Working Group	189-97
●Discussion
General Discussion−"What is the TGN 1412 case?"		201-15
●Instructions for authors [English]		217-22

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