SERVICES

Supporting the early phases of drug development.
Data integration
Documentation

 

  • Integration of in vivo and in vitro data.

  • Help in the definition of the first dose in human and optimal dose for subsequent phases.

  • Technical writing of non-GLP (Good Laboratory Practices) and GLP regulatory documents (Investigational New Drug, IND; New Drug Application, NDA), literature summaries.

Data analysis

 

  • Compartmental and non-compartmental, non-linear pharmacokinetic data analysis.

  • Integrated Biopharmaceutical-pharmacokinetic-pharmacodynamic modelling.

  • In vitro metabolism and mass balance.

  • Bioavalability and bioequivalences.

  • In vivo-in vitro correlations.

  • Analysis of dose frequency/dose duration.

Trial design

 

  • Proposal and planning of trials for preclinical development.

  • Design of in vitro ADME test (Absorption-Distribution-Metabolism-Excretion), metabolism, absorption, drug-drug interactions, dissolution, transporters.

  • Design of in vivo preclinical pharmacokinetic test, choice of species, number of animals, sampling intervals.

  • Design of in vivo human pharmacokinetic trials in early clinical phases.

  • Find solution to support Bioanalysis and method validation.

Biostatistics

 

  • Design of experiments.

  • Analysis of PKPD variability.

  • Model-based drug development and simulations.

  • Allometric scaling.

  • Population analysis.

Training

 

  • Customized training on any of the previous topics.

Software

 

  • Main developers of the free, opensource software Xcipion

  • Development of customized PK, PD, PKPD, PBPK, ... models in Xcipion

Kinestat Pharma