✦ LIBER ✦

Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy

✍ Scribed by A. Lindemann; F. M. Rosenthal; R. Mertelsmann; S. Hase; P. Markmeyer

Publisher: Springer
Year: 1995
Tongue: English
Weight: 443 KB
Volume: 73
Category: Article
ISSN: 0946-2716
DOI: 10.1007/bf00188142

No coin nor oath required. For personal study only.

✦ Synopsis

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 drugs. Major aspects of drug production are similarly defined in this statute (e.g., product license, Sect. 13). Below, we summarize the guidelines and recommendations for conducting clinical studies in somatic-cell therapy and gene therapy.

In addition to laboratory licenses, a number of other aspects of drug production and rules regarding the design of clinical protocols must be considered. For example, all clinical protocols must be submitted to the government agency of the state (Land). This agency has a cer-Founding Members of the German Working Groups for Gene Therapy (Deutsche Arbeitsgemeinshaft ftir Gentherapie

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