Accredited Bioanalytical Expertise for Drug Development
Proteomics International provides comprehensive pharmacokinetic (PK) testing to support preclinical and clinical drug development. As an ISO 17025-accredited bioanalytical laboratory, we specialize in targeted mass spectrometry, delivering precise and reliable drug quantification and metabolite analysis.
Why Choose Proteomics International for PK Testing?
- ✓ Advanced LC-MS Expertise – High-sensitivity liquid chromatography-mass spectrometry (LC-MS) for method development, validation, accurate drug and metabolite quantification.
- ✓ Diverse Sample Processing – Expertise in diverse biological matrices such as plasma, whole blood, urine, etc.
- ✓ Small & Large Molecule Bioanalysis – Supporting small molecules and peptide-based therapeutics.
- ✓ High-Throughput Automation – Cutting-edge liquid handling robots ensure efficient, reproducible results.
- ✓ Regulatory-Ready Data – Compliant with global bioanalytical standards.
- ✓ Quick Results – Proteomics International delivers fast and accurate pharmacokinetic results, with the ability to provide results within three-five days of receiving samples upon request.
- ✓ R&D Tax Incentive – The Australian Government’s Research & Development Tax Incentive offers significant benefits for research conducted in Australia. Eligible companies could recover up to 43.5% of every dollar spent on R&D. Proteomics International can refer you to tax advisors for simple and cost-effective access to these benefits.
Projects successfully undertaken include:
- Amphotericin B
- Dopamine
- Dutasteride
- Entecavir
- Gliclazide
- Palbociclib
- Ibrutinib
- Other first-in-human (FIH) studies
FAQ
Is method validation conducted in accordance with any relevant standards?
Method validation procedures are guided by the latest ICH M10 guidelines.
What accreditation do we have?
Data analysis is undertaken in accordance with the international standards:
a) ISO/IEC 17025:2017 (Chemical Testing); and
b) ISO/IEC 17025:2017 (Research and Development)
Accreditation to the ISO 17025 laboratory standard ensures laboratories generate technically valid results.
Which molecules can we analyse?
Novel and Existing Peptides & Small molecules – including Cannabinoids
What equipment do we use?
We have a range of state-of-the-art equipment including robotic solid phase extraction (SPE) and robotic liquid handler, LC-MS/MS and HPLC with UV.
Do we provide analysis of data?
Yes, we use Certara Phoenix® WinNonlin® software to provide common pharmacokinetic parameters, including Cmax, Tmax, t1/2 , AUC, AUCinf, CL, λZ, Vd, F and more.
Do you provide a full Bioanalytical Report?
Yes, we do. We can provide a comprehensive Bioanalytical Report that includes all relevant method details, validation data (if applicable), and study results in compliance with regulatory standards.
📩 Planning your new clinical study or Bioequivalence (BE) study with PK requirements?
Submit your enquiry here and our team will get back to you promptly with tailored solutions.
Biomarker Discovery and Validation
Understanding Drug Action & Effect
Beyond PK testing, Proteomics International offers pharmacodynamic (PD) biomarker discovery and validation to assess drug efficacy and mechanism of action.
Key PD Capabilities Include:
✔ Protein Biomarker Discovery & Validation – Identifying key indicators of drug response.
✔ Targeted Protein & Peptide Analysis – Precise quantification of discovered pharmacodynamic biomarkers.
✔ Custom Assay Development – Bespoke PD assays tailored to your drug development needs, with the potential for Companion Diagnostic (CDx) or Complementary Diagnostic translation.
Our integrated PK/PD expertise gives insights into drug metabolism, efficacy and patient response. Download PK/PD brochure
📩 Reach out to explore how our PD services can enhance your research. Submit your enquiry here and our team will get back to you promptly with tailored solutions.