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GLP Neurotoxicology

Nonclinical CNS safety pharmacology and neurotoxicology studies designed in rodents and Gottingen minipigs

 

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MD Biosciences performs CNS safety pharmacology and neurotoxicology studies according to Good Laboratory Practices (GLP). In addition to the listed studies below, other GLP studies and analysis are performed as required. Please contact us for a specific outline or to customize a study for your needs. 


 

CNS Safety Pharmacology Study

Purpose: To assess the drug candidates in the rat for effects on CNS safety pharmacology endpoints such as the functional observation battery.

Species: rat, subcutaneous

Compliance: GLP

Parameters: 

  • Open Field for locomotor activity
  • Catwalk for paw spread
  • Motor function score
  • General observation for CNS abnormalities
  • Tissue collection and analysis

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Single Dose toxicity and toxicokinetic Study

Purpose: To assess the toxicity of drug candidates in male and female animals.

Species: rat

Compliance: GLP

Parameters:

  • Sample collection at specified times
  • Collection and analysis of samples for toxicokinetic assays
  • Tissue collection and analysis

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Single Dose perineurial toxicity and toxicokinetic study

Purpose: To characterize the local (perineurial) and systemic toxicity and toxicokinetics of drug candidates. 

Species: rat

Compliance: GLP

Parameters: 

  • Tissue collection and analysis
  • Blood draws for chemistry and hematology (standard panels) at designated timepoints
  • Full veterinarian examination in the entire duration
  • Collection of organs per veterinary pathologist list, evaluation of all collected organ tissues by expert histopathological analysis
  • Daily clinical signs and body weight

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Cardiovascular/ Pulmonary Safety Pharmacology study

Purpose: To assess the drug candidate for effects on cardiovascular and pulmonary safety pharmacology endpoints.  

 

Species: minipigs

Compliance: GLP

Parameters:

  • Mean arterial pressure
  • Systolic arterial pressure
  • Diastolic arterial pressure
  • Pulse Pressure
  • Heart rate
  • PR interval, QRS duration, QT/QTc interval
  • Body Temperature
  • Respiratory rate
  • Tidal volume
  • Minute volume
  • Heart and lung harvesting for histology 

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Single Dose perineurial toxicity and toxicokinetic study

Purpose: To characterize the local (perineurial) and systemic toxicity and toxicokinetics of drug candidates. 

Species: minipigs

Compliance: GLP

Parameters: 

  • Tissue collection: nerve and surrounding tissues

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Ready to discuss your project?

If you are ready to discuss how electrophysiology can add to your understanding of your therapeutic potential, our scientists are eager to explore the possibilities with you. Like many other pharmaceutical and medical device developers, you can rely on predictive preclinical data.  

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