PK studies

Our highly experienced pharmacokineticists perform a variety of pharmacokinetic analyses, including non-compartmental and compartmental analysis, and PK/PD analysis.

All design analysis and reporting are based on ICH guidelines, following your needs and Biotrial’s SOPs

  • Understand Drug Exposure
  • Determine Appropriate Dosage
  • Manage Changes in Dosage Requirements
  • Estimate Elimination and Absorption Rates
  • Recognize Intra-Subject and Inter-Subject Variability
  • Understanding Drug Concentration-Effect Relationships

In Vivo Pharmacokinetics

Biotrial provides in vivo pharmacokinetic research and tissue distribution research services.

  • Animals: rodent and non-rodent
  • Method of administration: Intravascular/Subcutaneous/Intramuscular/Intraperitoneal/Per Os, etc.
  • Biological samples: Plasma, whole blood, Cerebro Spinal Fluid (CSF), bile, and other fluid biological matrices.
  • Organs: Distribution experiment and Blood Brain barrier (BBB) transmission experiment of the brain, Cerebro-Spinal Fluid, liver, heart, and kidney etc.
  • Excretion: Feces, urine, bile, etc.

What kind of analysis ?

For preclinical and clinical studies:

Non-compartmental analysis (NCA)

  • Experience with numerous clinical designs: SAD/MAD, Hepatic impairment, DDI, Food-effect, Bioequivalence, Patient studies with sparse sampling, Biosimilars, and more…
  • Knowledge of PK and statistical analysis guidelines

Compartmental analysis (CA) for mechanism understanding (ex: bi-phasic profiles)

  • Modeling of PK profiles to estimate PK parameters
  • Prediction of PK profiles according to dosing regimen

Pharmacokinetic-Pharmacodynamic analysis

  • PK-QT and other PK-PD models

Population pharmacokinetics

  • Preferred partnership

Which supporting activities ?

  • Advice on synopsis, protocol writing, statistical analysis plan
  • Interim analysis for preclinical studies
  • Interim analysis for clinical studies (ex: SAD/MAD study, IH/IR)
  • Sample size estimations (BE, DDI studies)
  • Production of TFLs (Tables, Figures, Listings)
  • Writing of PK section for CSR (ICH format) or a dedicated PK report


Pharmacokinetics and telemetry in the minipig
Evaluation of the sensivity of the qt assay

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