Part of the Clinical Sciences team, the Pharmacometrics group has a working knowledge
of pharmaco-statistical models and application of statistical, PK and PD principles
to accelerate Drug Development. It offers industry-experienced Data Managers, Pharmacokineticists,
Programmers and Statisticians with expertise in multiple therapeutic areas across
Phase I-IV trials.
Pharmacometrics activities can be offered as part of a fully integrated clinical
plan providing highly qualified expertise from protocol design till dissemination
of results. However, Pharmacometrics can also provide stand-alone services always
within the framework of ICH/GCP ensuring the highest standard of data analyses.
In the planning phase of a clinical study Aptuit Pharmacokineticists and Statisticians provide input as far as:
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Selection of optimal study design and appropriate level of blinding
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Prediction of human PK and therapeutic doses after a thorough review of all preclinical
in vitro and in vivo pharmacology and toxicology data and MABEL (Minimum Anticipated
Biological Effect Level) estimation
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Selection of appropriate time points of PK and PD measurements
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Sample size, Randomization and Statistical Methods adequate to the study objectives
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Exhaustive description of all the statistical methods performed on the data to be
collected (the statistical analyses plan - SAP), prepared and approved before clinical
data base is frozen
After study operations completion Aptuit Pharmacometrics performs the following data analyses steps:
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Unblinding of the randomization (if the study is blinded), once the database is cleaned-up and frozen
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Descriptive and inferential statistical analyses (eg. univariate to multivariate
analyses, linear and logistic regression, mixed-models for cross-over or longitudinal
trials, nonparametric analyses of categorical data, interim Bayesian monitoring
of adaptive designs)
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Application of evidence-based drug development approaches to investigate the relationship
between drug dose, plasma concentration, biophase concentration (PK) and drug effect
or side-effects (PD)
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Application of model-based approaches to suggest decision making tools based on advanced methodologies in modelling and simulations
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Tables, Listing and Figures showing the relevant study results as agreed in the SAP
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Integrated Pharmacometrics Report collating the contribution of Statisticians and
Pharmacokineticists, describing the methods applied and presenting the key results
supported by interpretation
Gold standard software such as SAS, WinNonlin Pro (Pharsight Corporation), NONMEM
(Globomax inc) and Winbugs are used within Pharmacometrics. All analysis output
produced (tables, listings and figures) undergo an appropriate level of Quality
Check (QC) revision before being disseminated.