Definite human ADME insights from Phase 1
Peregrion is a specialized CRO supporting pharma and biotech companies with human mass balance, metabolite profiling and absolute bioavailability data already from Phase 1 via microtracer technology. By reducing radiation doses at least 100-fold, we can generate critical PK data already in early clinical development.
End-to-end capabilities
for microtracer studies
Full design support for radiolabeled studies
Using our experience with more than 100 drug assets we team up with you to support decisions on position of radiolabel(s), dosing and formulation, 14C-synthesis, clinical design, bioanalytical methods, metabolite profiling.
15+ years of AMS expertise
In the past 15+ years, Peregrion (spin-off from TNO) supported AMS studies for more than 50 pharmaceutical and biotech companies and we have co-authored 13 peer-reviewed papers with companies like AstraZeneca, BMS, Merck KGaA, Novartis, PTC Therapeutics, and Pfizer.
100% focused on AMS-enabled studies
We are solely focused on Mass Balance, Metabolite Profiling and Identification, and Absolute Bioavailability studies. We take pride in our service levels and Quality standards.
Teamwork with our scientists
Direct interactions of scientist to scientist, no account managers in between, regular progress meetings throughout the study.
Services
AMS-enabled services for early clinical development
Traditionally, finding out exactly how a new drug asset transits and metabolizes inside the human body happens very late in the process. By the time human ADME is finally tested you’ve invested large amounts of time and resources with the risk of finding a human unique metabolite late during development.
At Peregrion, we’re changing this timeline. Our AMS technology enables pharmaceutical teams to obtain complete human mass balance, metabolism and bioavailability data as early as Phase 1/2a.
Absolute Bioavailability
Many regulatory agencies request information on the absolute bioavailability of orally dosed drugs. The study is often conducted as part of a two-arm study and provides, together with the mass-balance and metabolite profiling study, information on absolute bioavailability, first pass effect and fraction absorbed.
Mass Balance/Total Radioactivity (TRA)
You will receive a PK profile via measurements of total radioactivity, providing the routes, the rates and the quantity of total drug-related material in plasma and excreta. Mass balance data support the discharge of study trial participants from a clinical unit.
Metabolite Profiling
Metabolite profiling provides a comprehensive snapshot of metabolites in biological samples (e.g., plasma, urine, feces). The concentration of each metabolite is characterized using a combined UPLC+AMS approach, which is known for its ultra-high sensitivity.
Metabolite Identification
Metabolite identification provides the chemical structures and molecular formulas of metabolites derived from a parent drug. Human-unique metabolites need to be identified when these are >10% of the parent drug. Metabolites are identified by our trained experts using our state-of-the-art hrMS/MS systems.
Benefits of microtracer AMS vs
conventional radiolabeled studies
| Conventional radiolabel studies | Microtracer studies | |
|---|---|---|
| Human metabolites | Identified late (Phase 2b/3) → ADME on critical path | Identified early (Phase 1) → early risk mitigation |
| Dosimetry | Required (ICRP Class 2 / QWBA) | Not required before study |
| DDI & impairment studies | Based on in vitro + animal data | Can be optimized using early human ADME data |
| Sensitivity / dose | High dose (~100 µCi) required (LSC sensitivity ~0.5 Bq/LC) | Only 0.1-1 uCi required (AMS sensitivity is ~10 uBq/LC) |
| Study design (ADME & AbsBA) | Conducted as separate studies at therapeutic dose | Can be combined in a single cohort study |
| AbsBA design | Two-arm cross-over required | Determined in a one-arm, two-period study |
| IV toxicity | IV toxicity study required prior to human study | No IV toxicity data required |
| Fraction absorbed (Fa) | Separate studies do not allow determination of fraction absorbed (Fa) | Fraction absorbed can be determined in a two-period study |
| Material requirements | Full GMP material required | Qualified 14C material often tolerated |
| Formulation (IV) | Therapeutic dose formulations are complex for BCS II/IV (low solubility) | Microdose IV generally below solubility limits |
| Operational setup | Requires dedicated facilities | Can piggy-back on existing clinical trials |
| Value for de-risking | Aminal MB/MP studies required to de-risk | Early human data enables early MIST assessment |
Process
How AMS enabled microtracer studies add value to your clinical development process
Meet the scientific and operational team leads
Wouter Vaes
Co-founder of Peregrion BV and founder of the earlier established TNO AMS laboratories. Wouter has a background in a analytical chemistry and holds a PhD in Toxicology. He has over 25 years experience in leading GxP, ISO17025 and ISO9001 accredited laboratories.
Rianne de Ligt
Rianne is a pharmacist from training (MSc) and holds a PhD in Medicinal Chemistry/Molecular Pharmacology. She has over 20 years of experience in project management of GxP studies, is IPMC-trained and has a green belt (LEAN Six Sigma).
Esther van Duijn
Esther has a background in analytical chemistry and holds a PhD in (native) mass spectrometry. She has more than 10 years of experience as a scientist in AMS. She drives technological advancements for existing and new applications and focusses on scientific growth, quality and teamwork.
Latest insights and events
AMS Microtracer Studies in Early Drug Development: Wouter Vaes on the Clinical Pharmacology Podcast
AMS microtracer studies let teams generate human ADME and mass balance data early in clinical development, while there is still time to…
Peregrion at ISSX Europe 2026
June 29 – July 2, 2026 | Basel ISSX Europe 2026ISSX Europe is the leading European meeting on xenobiotic metabolism…
Peregrion at EBF Open Symposium 2026
November 17-19, 2026 | Barcelona EBF Open Symposium 2026EBF Open is the European Bioanalysis Forum’s annual symposium for the European…
