Tasso for PopPK

NEXT-GENERATION POPULATION PHARMACOKINETIC STUDIES

 

EXPAND YOUR STUDY’S REACH WITH DECENTRALIZED PATIENT-CENTRIC SAMPLING

Enhance your data density and fidelity with Tasso sampling solutions for population pharmacokinetics (PopPK). Our virtually painless, clinical-grade blood collection devices drive recruitment and retention through an improved patient-centric experience that can be completed anywhere. Tasso samples are compatible with your required sample logistics and bioanalytical workflows, streamlining the implementation process.

THE PROCESS

1.

DOSING EVENT

2.

TASSO KITS SUPPLIED TO PATIENT

3.

PATIENT COLLECTS BLOOD AT HOME

4.

SAMPLES SHIPPED TO LAB

5.

LAB ANALYZES SAMPLES

6.

PK DATA PROVIDED TO MODELING TEAM

Adaptable Study Design for Improved PopPK Modeling

TASSO’S END-TO-END PopPK SOLUTIONS ENABLE THE OPTIMIZATION OF YOUR DECENTRALIZED CLINICAL TRIAL DESIGN.

The remote, patient-centric sampling methodology enables better adherence and facilitates inclusion of more diverse populations, resulting in higher data density and fidelity than can be achieved with a clinic-centric approach. Design the right study for your requirements with the flexibility of our decentralized sampling solution.

 

THE BENEFITS OF TASSO SOLUTIONS FOR PopPK ARE CLEAR:

  • Collect samples at more timepoints, providing a richer dataset for modeling while enabling a reduction in trial subjects

  • Improved ability to study drugs with long half-lives, long-acting formulations, or episodic clinical endpoints such as migraine or asthma

  • Reduced sample volumes compared to conventional phlebotomy, enabling studies in children and vulnerable populations

  • Consistent sampling approach for all study participants and across clinical studies, enabling pooling of PK data

  • Sample volumes and formats that suit your logistics and bioanalytical assay workflow requirements

  • Demonstrated stability for room temperature sample shipping and storage results in reduced requirement for specialized equipment, such as refrigerated centrifuges

CONTACT US TO DISCUSS YOUR PopPK CLINICAL TRIAL DESIGN AND IMPLEMENTATION REQUIREMENTS

ROBUST LOGISTICS FOR SCALABLE STUDY IMPLEMENTATION

Tasso solutions deliver flexible integrated global logistics with multiple options for kit distribution and sample return, ensuring a good fit with your preferred PopPK study design. We provide end-to-end support for your study implementation.

  • Off-the-shelf kit containing all supplies for participant sampling and sample return can be provided directly to your clinical centers and/or participants

  • Adaptable use instructions available in multiple languages and formats

  • Personalized training available for sites and participants

  • Digital systems for timestamping and chain of custody monitoring

  • Barcoding and labelling compatible with most laboratory systems

  • Compliant with Personally Identifiable Information (PII) regulations

HIGH QUALITY SAMPLE ANALYSIS

Patient samples collected using Tasso solutions readily integrate into your bioanalytical workflows. Our precision blood collection systems support precise analytical results on a broad range of investigational compounds, with data collected by scientists on compounds ranging from small molecules to biologics.

Support resources are available for bioanalytical lab procedures using Tasso samples. Tasso offers solutions for the creation of calibration standards and quality control samples, as well as certificates of accuracy and material control for collection devices. There is established regulatory acceptance for capillary and dried blood technologies in the context of PK and PopPK data when the appropriate validations are performed. Tasso can advise on the best practices for successful implementation.

PARTNERSHIPS FOR SUCCESS

Tasso can work with your existing preferred providers for services such as remote dosing, logistics, bioanalysis, or PopPK modeling. If you prefer, Tasso can help you connect with our established network of provider partners.
Together, we can facilitate the rapid and successful implementation of your PopPK strategy.

WHAT IS POPULATION PHARMACOKINETICS FOR DRUG DEVELOPMENT?

PopPK is a well-established mathematical modeling methodology for understanding the observed variability in circulating drug concentrations between individuals, and as a result can minimise the variability in treatment response of patients. With this approach, only a limited number of samples are taken from any given patient, compared to traditional PK rich sampling.

PopPK data can alleviate the need for post marketing commitments to generate further data for specific patient groups based upon intrinsic (body weight, presence and extent of hepatic or renal impairment, genetic polymorphisms) and extrinsic (effect of food on absorption, concomitant medications effect on absorption and/or metabolism) factors, differences in dose, route of administration, etc. Additionally, the lower blood volumes obtained through sparse sampling methods, such as PopPK, facilitate studies in children and vulnerable populations.

 

PopPK REGULATORY REFERENCES

This approach is routinely accepted in submissions by regulatory authorities, including the FDA and EMA.

  • Population Pharmacokinetics - Guidance for Industry (2022) US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER).
    GET THE GUIDE

  • Guideline on reporting the results of population pharmacokinetic analyses, European Medicines Agency, Doc. Ref. CHMP/EWP/185990/06 (2007).
    GET THE GUIDE

CONTACT US

Learn more about how the convenience of Tasso’s patient-centric remote blood collection solutions can have a positive impact on your PopPK clinical study design.