Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

Pharmaceuticals, biopharmaceuticals, and phytopharmaceuticals

For risk assessment and registration, we offer toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies in rodents and – in cooperation with other institutions – also in non-rodents, in addition to in-vitro studies. In compliance with the international ICH registration guidelines, these studies are performed under GLP conditions. We furthermore support you in the registration of your pharmaceuticals, biopharmaceuticals, and phytopharmaceuticals by completing what has been demanded by the competent authorities and preparing the necessary documentation. Clients benefit in particular from the close dovetailing of basic research and applied research. This allows guideline studies to be complemented whenever necessary by further investigations using novel toxicological and molecular toxicological methods.

Overview of our services

In vivo

  • Subacute and subchronic studies using different routes of administration
  • Chronic toxicity and/or carcinogenicity studies
  • Pharmaco- and toxicokinetic studies (ADME)
  • Reproductive toxicity studies (studies on prenatal toxicity, on pre- and postnatal effects, fertility studies)
  • Evaluation of influences on lactation, juvenile animal studies
  • Histopathological investigations
  • Immunotoxicological investigations
  • Safety pharmacology testing

In vitro

  • Micronucleus assay in vitro and in vivo
  • Chromosomal aberration test in vitro (V79, human lymphocytes)
  • Mammalian cell gene mutation test in vitro (mouse lymphoma TK assay)
  • Bacterial reverse mutation assay (Ames test and Ames fluctuation test)
  • Acelluar, in vitro, and ex vivo comet assay (alkaline, neutral, modified protocol for detection of cross-links or oxidative DNA damage)
  • Demonstration of apoptotic DNA fragmentation
  • Detection of toxicity by cytotoxicity assays (NRU, LDH, WST etc.)
  • Measurement of intracellular endpoints by photometric, luminometric, and fluorimetric methods in multi-well systems

Your benefits

  • Access to a comprehensive range of methods
  • Custom-made concept for registration
  • Many years of cooperation with clients from the research-driven
    pharmaceutical industry
  • Efficient cooperation with registration authorities
  • Support throughout the entire registration process
  • By serving as advisors in various committees, we are always up to date on changes in the relevant guidelines
  • As a non-university research institution, we can be a partner in applying for public funding

Contact

Henning Weigt

Contact Press / Media

Dr. Henning Weigt

Head of Institute Strategy and Communication

Phone +49 511 5350-329