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Research services

Isoquimen has several years of experience in the performance of different Studies in Beagle dogs and cats.

Pre-clinical studies

  • Pharmacokinetic/ Bioequivalence
  • Bioavailability
  • Tolerance
  • Bioactivity/Efficacy
  • Toxicity (rodents)

Immunological studies

  • Vaccinal batch release testing
  • Safety of active and inactive vaccines
  • Duration of immunity (DOI) Studies
  • Sensitization against different antigens
  • Immunization and production of polyclonal antibodies

Nutritional studies

  • Palatability
  • Digestibility
  • Tolerance

Added values

  • Multiple routes for test item administration
  • Serial blood sampling in all species
  • Compound screening
  • Biomarker analysis
  • Bioanalysis
  • PK calculation & Stadistics
  • Flexibility to fully coordinate tasks with your research
  • GLP compliance (if required)


 


    Regulatory Guidelines

  • ICH: S3A Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies.
  • VICH Topic GL43 Guideline on target animal safety for veterinary pharmaceuticals products.
  • ENV/JM/MONO (2000)7 Guidance Document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation.
  • EMA/CPMP/ICH/286/1995 December 2009. ICH Guideline M3 (R2) on non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.
  • EMA/CVMP/016/00-Rev.2 April 2011. Guideline on the conduct of bioequivalence studies for veterinary medicinal products
  • EMA/CVMP/EWP/206024/2011  July 2014. Guideline on the demostration of palatability of veterinary products.


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