By providing state of the art modelling and simulation
support, we enable our clients to make informed
decisions and ensure that the right drug candidate is given at the right dose to the right
Population Pharmacokinetics (popPK)
We offer a thorough description of pharmacokinetic behaviour within a
patient population, including quantification of variability, and relating the variability to
various intrinsic/extrinsic factors and assessing potential drug-drug interactions.
Population Pharmacodynamics (popPD)
We offer an evaluation of the biochemical and physiological effects of
drug exposure within a population, creating semi-mechanistic population models capable of
assisting key decision making.
Our capabilities allow us to analyse a wide variety of response data for
both efficacy and safety endpoints, relating outcomes to exposure/dose rate. Regression
analysis, time-to-event analysis and ANOVA are just some examples of what we offer.
We offer an informed extrapolation plan based on popPK/PD models developed
for paediatric patients, allowing us to support the development of the PIP, assist initial
dose selection and advise throughout treatment development.
Optimal Trial Design
Our techniques allow a quantitative-based approach to trial design,
allowing study design decisions such as number of individuals, dose levels and sampling
times to be grounded in a robust mathematical framework.
Our expertise in statistical analysis allows us to evaluate ECG and PK
data and assess potential for QT prolongation. We can provide submission-ready C-QTc reports
to assist building the case against a dedicated thorough QT-study. Furthermore we can offer
state-of-the-art analysis of a thorough QT study.
Our team are able to create analysis-ready data sets for pharmacometric
analysis, NCA or for use in a clinical study report. Preparation of datasets will be done
under supervision by a senior scientist/modeller in order to produce ready-to-use
Our significant industry experience of 30 years allows us to provide
advice and guidance on regulatory strategy, perparing for meetings with authorities,
participating in meetings and support in preparing key documentation for IND, NDA, PPSR /
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