๐”– Bobbio Scriptorium
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Guidelines for implementation of clinical studies on surgical antimicrobial prophylaxis (2007)

โœ Scribed by Yoshio Takesue; Hiroshige Mikamo; Soichi Arakawa; Kenji Suzuki; Haruo Sakamoto; Takashi Okubo; Junzo Shimizu; Takashi Yokoyama


Publisher
Springer
Year
2008
Tongue
English
Weight
269 KB
Volume
14
Category
Article
ISSN
1341-321X

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According to Sects. 2 and 3 of the German drug statute, (Arzneimittelgesetz, AMG) gene technology and gene therapy products as well as somatic cell therapy products are regarded as drugs and are therefore subject to Sects. 40 and 41, stipulating the requirements for clinical studies designed to test