SERVICES BY PRODUCT TYPE

Discovery and drug candidate selection

Citoxlab – Helping you put the right drug candidate forward

> Discovery and drug candidate selection

> First-in-man and IND

> From IND to NDA

Citoxlab has a whole range of services dedicated to early phase drug candidate selection and development, where test item quantities, time to results and price are optimized for fast and robust decision making.

Our LeadScreen services include all the essentials for lead optimization and drug candidate selection, from the earliest genotoxicity assays to background data in support of multi-endpoint in vivo toxicology studies. All LeadScreen studies are reported within 10 days following the experimental phase.

LeadScreen Genotoxicity

  • Mini-Ames
  • Mini-micronucleus
  • Miniaturized versions of regulatory tests

LeadScreen Safety

  • 2-day study
  • Four escalating dose-levels
  • Heart rate, ECG and arterial pressure

LeadScreen Pharmacokinetics

  • Three replicates
  • Six sampling times
  • Quantification of plasma test item levels
  • Calculation of Tmax, Cmax, AUC, t1/2, Cl, Vz and F% by WinNonlin v 5.0.1 software

LeadScreen Toxicity

  • Three animals per group
  • Vehicle and two dose-levels
  • 4, 7 or 14-day oral gavage
  • Clinical signs, body weight and food consumption
  • Hematology and blood biochemistry
  • Organ weights
  • Preservation of all main organs
  • Histopathology: liver, kidney, heart, lung, spleen and stomach plus target organ
  • Options: blood micronucleus detection for genototoxicity, toxicogenomics, biomarkers and toxicokinetics