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In vivo Early Safety Assessment

 

In vivo Safety Evaluation during Drug Discovery

For early safety and toxicity assessment, Pharmacology Discovery Services has over 30 years of experience conducting in vivo safety and early toxicity testing. Combined with the in vitro pharmacology and cell based in vitro toxicity services from our Partner Lab, Eurofins Pharma Discovery Services, our in vivo safety services can provide a comprehensive risk profile for your drug candidates at a stage when changes can still be met without a major impact to your project

We offer a complete list of qualified safety related in vivo models to detect the most commonly observed adverse events in CNS, cardiovascular, respiratory, renal, metabolic, and gastrointestinal functions using a broad panel of industry-standard outcome measures to build a toxicokinetic (TK) profile.  We can also provide specialized models, such as our emesis model, to address specific project needs.


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Validated Safety and Toxicity In vivo Models Include:

  • Maximum Tolerated Dose
  • 7-day or 28-day tox (non-GLP)
  • PK + tissue exposure, urinary excretion
  • Cardiovascular
    • Blood pressure and heart rate
    • Postural hypotension and tilt response
    • Arrhythmia and QTc interval
  • Neurological and behavioral effects
    • Functional Observation Battery (Irwin) profile
    • Convulsions
    • Autonomic signs
    • Locomotor activity and coordination (Roto-rod)
  • Gastrointestinal and metabolic effects
    • GI motility
    • Emesis
    • Gastric effects
    • Body weight and food consumption
  • Hepatic and renal function
  • Respiratory monitoring
  • Ancillary services: clinical chemistry, hematology, blood gases, gross pathology, histology and macroscopic and microscopic necropsy
In Vivo Safety Models
Model Name Item Number Species
Behavior, Modified Irwin Screen, Safety non-GLP 509500 Mouse
Behavior, Modified Irwin Screen 509600 Rat
Body Temperature, Safety non-GLP 511000 Rat
Bradykinin Potentiation 511300 Rat
Maximum Tolerated Dose, Autonomic Signs 560000 Mouse
Maximum Tolerated Dose, Autonomic Signs 561600 Rat