KineStat Pharma
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
Kinestat Pharma