At Pharmetheus, we offer support to our clients in developing an extrapolation plan, drafting and executing a PIP/iPSP, and including body characteristics into population PK or PBPK modeling. These measures enhance accuracy and precision when considering parameters for dose adaptation in special populations.
Insights into pharmacokinetics for dose adaptation
Whether studied in a dedicated trial or in a dedicated cohort, special populations require special attention when it comes to the quantification of their difference from typical adult patients. The impact of special populations’ features often resides on the pharmacokinetics of the drug, such as a lower volume of distribution or an impaired elimination leading to an accrued exposure. Another challenge posed with special populations is linked to the often smaller sample size studied, however adapted analysis methods can help mitigate this issue.
To support decision-making in special populations trials, we can recommend an appropriate platform:
To analyze both drug concentration (pharmacokinetic) and effects (pharmacodynamic) data using a population modeling approach. The adopted quantitative approach enables efficient integration of longitudinal information across subjects and across study protocols.
A quantitative framework to support and inform development program strategies and decisions.
When the objective is to leverage accumulated knowledge to inform mechanistic analyses and or achieve predictions beyond observations.
We offer regulatory-compliant solutions that ensure the effective use of data so that your team can more accurately characterize the potential effects of a drug and make decisions confidently with sufficient precision. Read more about our recommended solutions when it comes to special population trials.
At Pharmetheus, we understand the importance of providing efficient and effective support to our clients. Our milestone analysis solutions are designed to meet the unique needs of each project.
Pharmetheus offers a unique Embedded Scientist service, providing project support with essential knowledge in quantitative approaches.
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