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adme

ADME

CiToxLAB – Your one-stop CRO for laboratory services

ADME is the evaluation of absorption, distribution, metabolism and excretion properties of compounds and their metabolites. We can help you develop ADME testing strategies spanning early stage development, preclinical toxicity and through your clinical trials.

The synergy within our group gives you a head start for competitive time-lines and efficient advice. You gain easy assess to our experts and we can evaluate your precise requirements and ensure you get the best ADME package at the best price.

Pharmacokinetics and toxicokinetics

Pharmacokinetics help to characterize your compound profiles and provide valuable data on exposure levels of compounds and their metabolites after single and repeated compound administration. CiToxLAB gives you reliable absorption, distribution, metabolism and excretion property data to back up your compound development :

  • Compartmental and non-compartmental analysis with validated phoenix WinNolinTM software
  • Formulation or compound selection with LeadScreen PK
  • Bioavailability, bioequivalence, food effect studies
  • Mass balance ADME studies
  • PK/PD modeling and simulation
  • Statistical analysis with SAS® software

ADME bioanalysis

You need validated methods which are robust and reproducible, meet GLP standards and comply with current regulations. Our competence and reactivity, allied with state of the art apparatus, enable us to respond promptly.

In addition to a personalized bioanalysis service, our experience in the field of immunochemistry allows us to propose classic and innovative (calcitonin) biomarker follow-up. Our ICP-MS techniques for rapid quantification of metallic ions in various matrices cover just one of further services you can access within the scope of your project.

We can analyze a broad range of matrices including plasma, tissues, cerebro-spinal fluid and ocular liquid.

Here are some of the options:

Composition types

  • Peptides
  • Vitamins
  • Amino acids
  • Vaccines
  • And more…

 Biomarkers

  • Nephrotoxicity
  • Inflammatory
  • Complement factors
  • Immunotoxicity
  • Hormones

For therapeutic proteins and biomarkers

  • Ligand binding assay, ELISA, ECLA, RIA
  • Flow cytometry
  • Multiplex technology

For large molecules

  • β-blockers
  • Ligand binding
  • Flow cytometry
  • Multiplex technology

 For small molecules

  • HPLC and UFLC (with multiple detection)
  • Liquid scintillation and oxidization
  • LC-MS/MS and LC- ICP/MS
  • GC and GC/MS

Expertise

  • Method development and validation
  • Method transfer
  • Partial and crossed validations
  • Pre-clinical and clinical trials
  • Non-GLP discovery studies
  • Regulatory GLP studies

 

Radiolabelled compounds and DMPK

The DMPK department at CiToxLAB has a dedicated team of highly experienced scientists to support your preclinical studies. Radiolabelled and non-radiolabelled compound analytical methods are developed and validated for sample analysis in blood and tissues, radiochemical purity and specific activity.

Radiolabelled studies with various isotopes : 14C, .3H, .125I

  • Mass balance / excretion studies (including bile and expired CO2 collection)
  • Tissue distribution
  • Metabolic profiling
  • In vitro cutaneous penetration
  • In vitro plasma/blood partitioning
  • Plasma protein binding
  • Liquid scintillation counting (directly or after combustion)
  • Radio-purity
  • Kinetics

Induction studies

Cytochrome P450 (CYP) induction is one of the major factors that can affect the pharmacokinetics of a drug molecule upon multiple dosing. It not only leads to therapeutic failures due to lack of exposure, but also to drug-drug interactions with co-administered drugs. Many compounds increase the levels of CYP metabolizing enzymes, and identifying them is an essential part of drug development.

A recent revised draft FDA guidance on drug interactions (Guidance for Industry: Drug Interaction Studies, 2012) recommends the measurement of mRNA levels using human hepatocytes as the gold standard when determining induction potential of an investigational drug.

Studies of CYP in vitro induction using mRNA quantification by qPCR strictly adhere to the best practices for PCR quantification and validation, and our assays comply with the relevant international guidelines.

Combining the expertise of our in vitro toxicology and genomics teams, standard CiToxLAB studies include :

  • Initial cytotoxicity assessment in cryopreserved hepatocytes
  • Induction in at least three donors of cryopreserved human hepatocytes
  • Exposure to test item at five concentrations (determined from the preliminary cytotoxicity assessment)
  • Prototypical inducers (recommended by FDA) as positive controls: omeprazole (for CYP1A2), phenobarbital (for CYP2B6), and rifampicin (for CYP3A4; CYP2C8; CYP2C9; CYP2C19)
  • Assessment of RNA quality prior to quantification.
  • After an exposure period, induction levels are quantified by RT-qPCR and compared to reference genes