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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

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
• Flyer on histological testings
• Flyer on REACH

Miscellaneous

• General Terms and Conditions of Business
• GLP certificate
• GMP certificate
  

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  * 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.