ADME
CIT performs a wide range studies combining 14C- and 3H-radiometric procedures with modern HPLC or LC-MS/MS techniques. Our extended experience allows to adapt the design of the studies to each specific project.
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• Study types:
- Plasma/blood pharmacokinetics
- Mass balance, including collection of CO2 and bile
- Tissue distribution
- Bioavailability and bioequivalence
- Metabolic patterns
- In-vitro plasma protein and blood cell binding
- In-vivo generation of biological samples
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• Species:
All rodent and non-rodent species used in non-clinical and small animal veterinary clinical studies (including poultries)
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• Test item:
Radiolabelled (14C, 3H) or “cold compounds”
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• Duration:
Single or repeated administrations
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• Routes of administration:
- Standard routes: Oral (gavage, capsule), intravenous (bolus to continuous infusion)
- Non standard routes: intramuscular, subcutaneous, topical (cream, patch, liquid), intranasal, intraocular, intrarectal, intravaginal, inhalation, intravitreal
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• Determination of pharmacokinetics or toxicokinetics parameters:
WinNonLin or Kinetica.
BIOANALYSIS and ANALYTICAL CHEMISTRY
The department ensures development, transfer and validation of analytical methods following international recommendations and guidelines.
Our services include bioanalysis, on-line support for studies and determination of physico-chemical properties. Samples come from internal studies as well as external studies (sub-contracted work in multi-site studies).
The laboratory has state-of-the-art equipments with fully validated softwares:
- HPLC coupled with UV/Vis, DAD, fluorescence, Refractive Index, electrochemical and radiochemical detection
- LC-MS/MS: Applied Bio Systems, three API 2000 / API 4000 (triple quadruple)
- GC : coupled with ECD, flame ionisation and thermionic specific detection
- GC-MS: Varian Saturn 2000
- EIA
- Liquid Scintillation Counter and Packard Oxidiser
- EMPOWER software for data acquisition and treatment
- Walk-in deep-freezers equipped with an alarm system and secured by an electric generator
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• Bioanalysis
- Parent compound and metabolites
- All possible biological matrices (serum, plasma, urine, faeces, saliva, milk, tissues, etc.)
- Pre-clinical and clinical samples. Analyses are scheduled to integrate with the in vivo organisation of studies.
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• Analytical support for studies
- Validation of stability and homogeneity of the dosage forms
- Verification of concentrations prior to the start of the treatment phase and during the study (results are obtained prior to the use on that day).
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Map
Short term, tolerance and in-vitro toxicology