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Downloads
On this page you are invited to download scientific papers, presentations, press releases and additional informational materials:
Presentations
- Allergenicity and anaphylaxis testing
- Immunotoxicity studies
- Preclinical Toxicological Tests for new drugs
- GLP basic training for technical officers (in German)
- GMP basic training for technical officers (in German)
- General company presentation
Guidelines
- ICH Topic S8 „IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS“
- ICH Topic S6 „PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS“ (engl.)
Press Releases
- Journal „GIT-Laborjournal“ on Immuntoxicity
- Journal „Laborwelt“ Immunoassay-Optimierung (in German)
- press release September 05
- TEXCELL acquires vivo Science (May 2016)
External Authors
- Taylor/Pauels*: An overview of immunotoxicity guidelines
- Paffenholz**: Nonclinical assessment of immunotoxicity in the EU, United States, and Japan (Master’s thesis)
Further Informations
- Flyer on safety, toxicity, immunotoxicity and vivo testings_new
- Flyer on safety, toxicity, immunotoxicity and vivo testings
- Flyer on histological testings
- Flyer on REACH
Miscellaneous
- General Terms and Conditions of Business
- GLP certificate
- GMP certificate
* This article is „view-only“. © 2006 The Organisation for Professionals in Regulatory Affairs (TOPRA).** © 2005 Dr. Rainer Paffenholz / Deutsche Gesellschaft für Regulatory Affairs (DGRA) eV.