Clinical Pharmacology and Therapeutics Unit

Austin Health, Department of Medicine.


Mr. Andrew Ellis

03 9496 3220

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Post author: Andrew Ellis. Last update: 02/11/2015 at 3:11 pm by Andrew Ellis.


The Clinical Pharmacology and Therapeutics Laboratory, conducts the tailored development of customised tests for drugs in biological matrices for routine therapeutic drug monitoring and as support for clinical trials, pharmacokinetic studies and basic research. It also offers stability study capabilities for pharmaceutical preparations. Methods used include high pressure liquid chromatography (HPLC), gas chromatography mass spectrometry (GCMS). The laboratory is NATA-accredited to AS 4633 (ISO 15189) in the field of medical testing; categories include – ‘drugs for therapeutic monitoring’, and ‘biogenic amines’. Therapeutic drug monitoring services, research activities and clinical trial support have been provided for over 30 years and laboratory accreditation has been held since 1989. The laboratory is closely affiliated with the University of Melbourne Department of Medicine, Nucleus Network Clinical Trial Centre (Austin Campus) and the Austin Hospital Departments of Pharmacy and Pathology. Testing (NATA ISO15189 accredited) is currently offered for the following:

  • Therapeutic drugs in plasma/serum (Mycophenolic acid, Perhexiline, Clozapine, Oxypurinol).
  • Hormones/vasoactive agents (catecholamines – adrenaline, noradrenaline and dopamine in plasma and urine).

Liquid chromatography tandem mass spectrometry (LCMSMS) analytical capability will also commence in early 2010. The Clinical Pharmacology and Therapuetics Unit also contracts to the Therapeutic goods Administration (TGA) to evaluate regulatory submissions for new drugs.

Other infrastructure:

  • Accredited sample/specimen handling abilities via Austin Pathology.
  • Sample/specimen frozen storage facilities.
  • Co-management of the 16-bed Austin Clinical Trials Centre.



Know how:

  • Accredited bioanalytical quantitation of drugs/biomarkers/metabolites and hormones.
  • Pharmacokinetic study design, conduct and analyses.
  • TGA contracted evaluation of regulatory drug submissions.
  • Staff that act as NATA medical testing technical assessor.
  • Pre-clinical and clinical trial study experience and capability.

Expertise:Availability of technical support:

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Clinical Pharmacology and Therapeutics Unit

Austin Life Sciences. Lance Townsend Building, 145 Studley Rd, Heidelberg, Victoria, Australia.

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Type: Core facility in a research organisation
Discipline areas: Biological Science
Precinct: Northern
Affiliations: Austin Health, The University of Melbourne

Biological Science categories: ADME, Analytical assays, Clinical trials resources, Data Analysis, Drug development, Gas Chromatography, GC, HPLC, HPLC, Mass spectroscopy, Mass spectroscopy, Metabolomics, Pharmacokinetics

Tags: chromatograph, drug assay, GCMS, HPLC, LCMSMS, mass spectrometer, mass spectrometry, pharmacokinetic