第３回次期治験活性化計画策定に係る検討会資料（平成１８年８月２８日開催）

CHMP guidance:small population etc

昨日付けで臨床試験・評価関連のガイダンス等が出ています：

Guideline on Clinical Trials in Small Populations
http://www.emea.eu.int/pdfs/human/ewp/8356105en.pdf
Overview of Comments received on Draft Guideline "Clinical Trials in SmallPopulations"
http://www.emea.eu.int/pdfs/human/ewp/28149006en.pdf

Appendix 1 to the Guideline on the Evaluation of Anticancer MedicinalProducts in Man
http://www.emea.eu.int/pdfs/human/ewp/26757506en.pdf

& Answers on the Bioavailability and Bioequivalence Guideline
http://www.emea.eu.int/pdfs/human/ewp/4032606en.pdf

Reflection Paper on the use of Pharmacogenetic in thePharmacokinetic Evaluation of Medicinal Products
http://www.emea.eu.int/pdfs/human/pharmacogenetics/12851706en.pdf

http://www.emea.eu.int/whatsnewp.htm

06/07/25 第２回 次期治験活性化計画策定に係る検討会

06/06/29 次期治験活性化計画策定に係る検討会第１回議事録

データマイニング手法の安全対策業務への導入に関する検討について