木曜日, 8月 28, 0020

月曜日, 8月 25, 0020

20080822 EMEA Question and Answer on records of study subject data relating to clinical trials

22/8/08 GCP The GCP IWG has released a Question and Answer on records of study subject data relating to clinical trials.
The GCP IWG receives many queries relating to the documentation of study subjects' participation in clinical trials. This Q and A is the first to be published by the GCP IWG on this topic.

http://www.emea.europa.eu/Inspections/GCPQaA.html

金曜日, 8月 22, 0020

200807 CHMP concept paper: Rev investigation of drug interactions

21/08/08 Concept paper/Recommendation on the need for revision of (CHMP)
Note for guidance on the investigation of drug interactions
http://www.emea.europa.eu/pdfs/human/ewp/29793108en.pdf

200807 CHMP draft guidance: GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE(CHMP)
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
DRAFT

http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf

200808 FDA draft guidance: ABECB-COPD

Rev.1 ドラフトが出ました(1998の(ドラフト)ガイダンス 
Acute Bacterial Exacerbation of Chronic Bronchitis DevelopingAntimicrobial Drugs for Treatment に対するもの)
Guidance for Industry
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs forTreatment DRAFT GUIDANCE
http://www.fda.gov/cder/guidance/4511dft.pdf