水曜日, 2月 27, 0020

20080213 第6回 厚生科学審議会科学技術部会臨床研究の倫理指針に関する専門委員会

http://www.mhlw.go.jp/shingi/2008/02/s0213-6.html

第5回臨床研究の倫理指針に関する専門委員会の主な意見
「臨床研究に関する倫理指針」の改正素案の概要(案)

木曜日, 2月 21, 0020

20080220 EMEA concept papers

20/02/08 Concept Paper on Haematological Malignancies Human Medicines Human Guidelines - Clinical Efficacy and Safety Guidelines http://www.emea.europa.eu/pdfs/human/ewp/2080808en.pdf

20/02/08 Concept Paper on the Development of a CHMP Guideline on the Clinical Investigations of Medicinal Products for the treatment of Pulmonary Hypertension Human Medicines Human Guidelines - Clinical Efficacy and Safety Guidelines http://www.emea.europa.eu/pdfs/human/ewp/56695407en.pdf

20/02/08 Concept Paper on Revision of the Points to concider on the Clinical Evaluation of New Agents for Invasive Fungal Infections Human Medicines Human Guidelines - Clinical Efficacy and Safety Guidelines http://www.emea.europa.eu/pdfs/human/ewp/1202508en.pdf

20/02/08 Concept Paper on Development of Guideline on the treatment of Attentional Deficit Hyperactivity Disorder (ADHD) Human Medicines Human Guidelines - Clinical Efficacy and Safety Guidelines http://www.emea.europa.eu/pdfs/human/ewp/2011908en.pdf

20080220 EMEA Guideline on the Evaluation of Anticancer Medicinal Products in Man

Guideline on the Evaluation of Anticancer Medicinal Products in Man - Methodological Considerations for Using Progression-Free Survival (PFS) as Primary endpoints in confirmatory trials for registration Human

http://www.emea.europa.eu/pdfs/human/ewp/2799408en.pdf