Pharmacokinetic Testing

Accredited Bioanalytical Expertise

Comprehensive suite of new pre-clinical and clinical testing capabilities: pharmacokinetic (PK), pharmacodynamic (PD), and companion diagnostic (CDx) services.

Proteomics International applies its proven expertise and experience in targeted mass spectrometry to the field of PK testing. Mass spectrometry is ideal for the accurate and precise quantitation of target drugs and their break-down products in biological matrices, the basis of pharmacokinetic testing.

Our workflows are capable of handling varying sample types including plasma, whole blood and urine.

Proteomics International’s high-throughput analytical capabilities, using state of the art LC-MS spectrometers and liquid handling robots, ensures that it is able to analyse a range of small molecule, large molecule, and peptide drugs in an automated manner, yielding efficient and accurate analysis.

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Services

      • Pre-clinical and clinical analytical services.
      • Method development of quantitative assays for drugs in biological matrices using industry standard LC-MS/MS systems.
      • Method development and validation is conducted in accordance with international recognised regulatory standards.
      • Sample testing and reporting utilises validated software.

Project specific quotations will be provided upon request.
Request Form: Pharmacokinetic Testing

 

Pharmacokinetic Testing Brochure

 

Quality | Accuracy | Speed

Quality Guarantee

Proteomics International stands behind the quality, timeliness and reliability of its services. If results are not delivered on time and do not comply with international recognised regulatory standards, charges may not apply.

Accreditations

Proteomics International is ISO/IEC 17025 accredited and operates in accordance with the OECD Principles of Good Laboratory Practice (GLP).

Quick results

Proteomics International delivers quick and accurate pharmacokinetic results, with the ability to deliver results within three days of receiving samples upon request.

R&D Tax Incentive

The Australian Government’s Research & Development Tax Incentive offers significant benefits to carrying out research in Australia. Eligible companies could recover as much as 43.5% of every dollar spent on research and development.

Proteomics International can refer you to tax advisors who can facilitate simple and cost-effective access to the R&D Tax Incentive.

 

Projects successfully undertaken include:

  • Amphotericin B
  • Dopamine
  • Dutasteride
  • Entecavir
  • Gliclazide

 

Frequently Asked Questions

Is method validation and project management conducted in accordance with any relevant standards?

Method validation procedures are guided by the US Food and Drug Administration guidelines “Guidance for Industry: Bioanalytical Method Validation” and the European Medicines Agency  “Guideline on Bioanalytical Method Validation”.
The management of research projects are conducted in accordance with the OECD Principles of Good Laboratory Practice.

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. The management of projects are conducted in accordance with the OECD Principles of Good Laboratory Practice.

Which molecules can we analyse?

Small molecules – Novel and Existing
Peptides.

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 we have an NDA form?

Yes, contact us for more information.

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