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Sampling and Sample Size Strategies

Optimal sampling (number and timing of samples) and sample size (number of patients) are strategic calculations to perform and establish in order to reach study objectives through efficient study design. PhinC can assist you in these important stages of clinical development.

Many Cases, Many Pharmacometric Solutions

For studies where rich sampling can be performed or if only sparse sampling is available, our experts will use appropriate tools (M&S: Modeling and Simulations, optimization techniques, etc.) to offer you an efficient sampling plan.

Cube Statistics

In the first case, we use preliminary information to build models for, predict and optimize future studies.This information is taken from PBPK, pharmacokinetic and preclinical or human PK/PD studies.

In the second case, such as with studies for specific populations (children, the elderly, complicated pathologies, etc.), our calculations are based on prior knowledge (i.e. PK, PK/PD, PK/efficacy or PK/safety in clinical trial simulations) and optimization tools are used. This ensures sampling optimization by increasing the precision of the parameters and strength of the conclusions.

Based in Ethical and Clinical Reality

As mathematical calculations are sometimes reliable but not adaptable for practical use, PhinC is conscious that these calculation results must fit in with clinical reality.

PhinC experts know how to find a precise equilibrium between the sufficient number of subjects required in order to form a reliable prediction and the most amount of samples (of blood for example) that investigators can ethically obtain from their patients. Also, calculations are based on clinical environment constraints to adapt the sampling plan to all issues that come up in practice, in real time.