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Preclinical Bioanalysis & Toxicokinetics

Robust Preclinical Bioanalysis Toxicokinetics

Preclinical development is where data quality becomes non-negotiable.

BioNotus provides fit-for-purpose and GLP-ready bioanalysis to support exploratory and regulated toxicokinetics studies across species and matrices.

We focus on generating reliable data that directly supports dose justification, safety interpretation, and regulatory decision-making, without unnecessary complexity or over-engineering.

→ Exploratory and GLP toxicokinetics (TK)
→ Cross-matrix bioanalysis (plasma, tissues, CSF, complex matrices)
→ Small molecules, peptides, biologics, mAbs, ADCs
→ GLP-certified non-compartmental analysis (NCA)
→ Seamless transition from exploratory to regulated studies
Discuss Your Preclinical Study

Advanced Molecular Biomarker Characterisation

Understanding what is in your samples, and why it matters, is critical before entering the clinic.

BioNotus applies advanced mass spectrometry and ultra-sensitive biomarker platforms to characterise drugs, metabolites, proteins, and safety markers in preclinical studies.

Our approach combines high-resolution molecular detail with multiplexed biomarker insight, enabling early identification of liabilities and translational signals.

→ Advanced LC-MS/MS and high-resolution MS (Orbitrap, QTOF)
→ Proteomics: intact proteins, peptide mapping, PTMs
→ Metabolomics, targeted and untargeted analysis by MS
→ Biomarker panels measured alongside PK/TK samples
→ Ultra-sensitive multiplex immunoassays for low-abundance markers
→ Suitable for complex matrices and limited sample volumes
Explore Biomarker & Bioanalytical Options

Mechanistic Modeling Translational Insight

Preclinical data only creates value when it informs the next decision. 

BioNotus integrates bioanalysis, biomarker data, and mechanistic modeling to translate preclinical findings into clinically relevant insight.

Using Bayesian pharmacometrics and PBPK modeling, we help teams understand exposure–response relationships, anticipate human outcomes, and reduce uncertainty before first-in-human studies.

→PBPK and PK/PD modeling
→Hybrid and semi-mechanistic models
→Uncertainty and scenario analysis
→Dose justification and study design support
→Data packages aligned with regulatory expectations
Prepare My Program for the Clinic

Bioanalysis, biomarkers, and modeling delivered by one senior team, with one scientific narrative.

Talk to a Preclinic Expert