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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.

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