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.

Specific populations require special attention when it comes to the quantification of their difference from typical adult patients, whether studied in a dedicated trial or in a dedicated cohort. 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 specific 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:

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.