PK Studies AMS

Thema:
Efficient drug development

De-risk and accelerate drug development with TNO’s exclusive auto-combustion-based AMS technology. Each Phase I, first-in-human (FIH) study can be a MIST and Mass Balance study, for faster, economical and accurate drug development. With TNO’s microtracer expertise, drug development becomes a streamlined and targeted process. Our advanced and accurate testing capabilities reduce animal testing and ensure early knowledge of the ADME of a drug in humans.

How can AMS accelerate drug development?

Swift, effective testing

Current Human ADME studies are often conducted in the late stages of drug development. If and when metabolites are discovered at this late stage, biotech companies face the sometimes-insurmountable challenge of still gaining approval for the drug.

Next-level data collection

TNO’s microtracer technology can deliver simultaneous MIST and Mass Balance data that enables companies to directly identify human metabolites in the development process (Phase 1). With the ability to detect and identify metabolites at such an early development stage, biotech companies no longer need to spend years – and budget – pursuing a drug development that will require additional, excessive toxicology studies.

Game-changing sample preparation

TNO has the unique ability to fully automate blood, plasma, urine or fecal sample analysis by AMS, based on auto-combustion. This differs significantly from the standard graphitisation-based approach. Auto-combustion sample preparation allows us to analyse more samples per day, ensures a faster turnover time, and is more economical because it is far less labour-intensive. It also eliminates the need for material recovery and reduces recovery time for human volunteers.

Unique expertise

TNO is the only organisation in Europe with a biomedical Accelerator Mass Spectrometer (AMS) that enables automated CO2 combustion AMS. We were the first to conduct a microdose study using a biopharmaceutical, and also the first to perform a microtracer study in pediatric patients.

In a microdosing study, very small doses (< 100 µg) are administered to human volunteers, who do not experience any physical effect from the drug. However, microdosing levels are high enough to be measured at TNO's state-of-the-art AMS facility, and provide real human PK data. This is more valuable than pre-clinical animal testing, and reduces the number of test animals. This is fully in line with TNO's mission to refine, reduce and replace animal testing with faster, more accurate alternatives.

Want to know more about how TNO can accelerate and streamline your drug development as early as Phase I? Contact Wouter Vaes for more information.

Get inspired

8 resultaten, getoond 1 t/m 5

TNO helps accelerate drug development through insight

Informatietype:
Insight
14 November 2022

To find the most effective interventions for complex metabolic diseases, we must first understand the dynamics of disease onset and progression. Only then can key targets and optimal therapeutic windows for more effective treatment be defined. We spoke with Anita van den Hoek, Research Scientist for TNO Metabolic Health, about how TNO helps pharmaceutical companies accelerate drug development through better understanding of disease pathways.

TNO proves method for effective pediatric drug development

Informatietype:
Insight
14 November 2022

Safe and effective drug dosing for young children come with their own challenges. Up to the age of 18, a child’s metabolism can change significantly. And in the first two years of life, those ontogenic differences can be rapid and dramatic. TNO published its findings from the first drug disposition (mass balance/metabolite profiling) study to conclusively prove that microtracing with accelerator mass spectrometry (AMS) is an effective way to collect clinical data in these young patients. This AMS technology can also be the key to building up more data on drug interventions in pregnant and lactating mothers.

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Informatietype:
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