TetraQ is a GLP recognised facility, fully accredited with NATA. With over 10 years of operation, we have extensive expertise working with both local and international companies to support clinical and preclinical studies. Bioanalytical studies and pharmacokinetic analysis are conducted in house with the capacity to analyse large sample volumes and tailor sample turnaround time to provide rapid results as you require.
TetraQ is highly experienced in developing bioanalytical methods for quantitation of novel compounds in a range of biological matrices including plasma, serum, faeces, urine, bile and tissue homogenates, from a range of species, using a variety of methods including robotic SPE, LC-MS/MS, HPLC-MS/MS, HPLC with UV or fluorescence detection, GC-MS, GC-FID and ELISA methods. TetraQ has a very extensive library of validated bioanalytical methods.
TetraQ provides also provides an extended range of GLP services including in vitro metabolism studies in hepatocytes, expressed CYP's liver microsomes or cytosol, as well as in vivo pharmacokinetic and toxicokinetic studies in rodents
Using state of the art instrumentation and technologies, the bioanalytical methods are developed "fit for purpose" from screening assays right through to full validation required by regulatory agencies such as the FDA, EMA and the TGA. The level of method validation required depends upon your stage of drug development, and we are happy to tailor this to your needs.
Our chief service capabilities include;
- Bioanalytical Method Development and Validation including LC-MS/MS, HPLC, and ELISA assays,
- Sample analysis of compounds and metabolites in human and animal samples
- Clinical trial samples analysis and pharmacokinetic studies
- In vitro and in vivo ADME bioavailability and pharmacokinetic studies
- Toxicokinetic studies
- Biodistribution studies
- Metabolic Screening & Profiling studies
- Biological Stability Testing
- HPLC Analysis
- LC-MS/MS Analysis
- ELISA Analysis
- Plasma Protein Binding
- Radioisotope Analysis
- Other ADME services available at TetraQ include, plasma protein binding, plasma and tissue homogenate stability, biodistribution studies and pharmacokinetic parameter estimation