ADME and Bioanalysis

CIT performs a wide range studies using modern HPLC or LC-MS/MS techniques performed with radiolabelled or non radiolabelled compounds. Our extended experience allows to adapt the design of the studies to each specific project.

ADME

Study types:

Plasma/blood pharmacokinetics
Mass balance, including collection of bile and expired CO_2.
Tissue distribution
Bioavailability and bioequivalence
Metabolic patterns
In vitro plasma protein and blood cell binding
In vivo generation of biological samples

Species:

All rodent and non-rodent species used in non-clinical and small animal veterinary clinical studies (including poultries)

Test item:

Radiolabelled (¹⁴C, ³H) or “cold compounds”

Duration:

Single or repeated administrations

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

Determination of pharmacokinetics or toxicokinetics parameters:

Dedicated WinNonLin 21 part CFR compliant validated software (version 5.0.1).

BIOANALYSIS

The department ensures development, transfer and validation of analytical methods following international recommendations and guidelines.

Our services include bioanalysis and 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: AB Sciex, 7 in total : 2*API 3000 and 2*API 4000.
GC : coupled with ECD, flame ionisation and thermionic specific detection
GC-MS: Agilent (780 A).
EIA (Enzymo Immuno Assays).
Liquid Scintillation Counter and Packard Oxidiser
EMPOWER and ANALYST softwares for data acquisition and treatment
Walk-in deep-freezers equipped with an alarm system and secured by an electric generator

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.

Analytical support for studies

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).