Toxicology Studies

Infection Control in Clinical Studies

For safety assessment of new drug candidates various animal models are currently used to detect specific immunotoxic side effects and to discriminate toxicity from efficacy of immunomodulatory drugs. Unfortunately, due to antibiotic regime conventional animal monitoring based on blood culture can lead to false-negative results.
Based on UMD technology, Molzym has developed a range of methods for monitoring microbial infections. These methods have been successfully applied to various animal models and a wide range of clinical sample types (e.g., blood, other body fluids, tissue).

Molzym provides the following microbial monitoring services:

  • Various animal models
  • Various clinical specimens
  • Culture-independent microbial monitoring (Real-Time PCR)
  • Custom method development

Case Study:

A pharmaceutical company planned a study on respiratory tract infections to determine the optimal effective dose to experimentally infected rat, using a respiratory tract infection with Actinobacillus pleuropneumoniae as respiratory infectious agent. Test item in 4 different doses was performed for 10 days. Among others, lung post-mortem quantitative bacteriology for the presence of Actinobacillus pleuropneumoniae in the lung of each rat was performed at the day of necropsy. Data collected from each individual animal and each study group was compared between the four study groups.

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