TetraQ offers a range of in vitro and in vivo ADME services for the analysis of drugs and metabolites in biological fluids:

Bioanalytical services
- Method Development
- Method Validation
- Analysis
- Toxicokinetics

In vivo ADME services
- Pharmacokinetics
- Toxicokinetics
- Metabolism Studies
- Tissue Distribution Studies

In vitro ADME services
- Plasma Stability
- Metabolic Screening/Profiling

Metabolism Studies
- Microsomes
- Human CYP's
- Hepatocytes
- Isolated Perfused Rat Liver

TetraQ-ADME holds ISO 17025 (R&D) accreditation and GLP Recognition according to OECD Guidelines.

We are able to provide a full spectrum of services ranging from generating fast feedback of in vitro data to assist in the Lead Selection Stage, through to developing fully validated assays for regulatory submissions.

TetraQ ADME incorporates the Centre for Studies in Drug Disposition (CSDD), which has worked closely with pharmaceutical companies for over 20 years, conducting bioanalytical, bioavailability/bioequivalence and drug-drug interaction studies.

Bioanalytical Services

TetraQ-ADME has a strong bioanalytical capability and can analyse samples generated from studies conducted in-house or from externally conducted studies. We are recognised as leaders in the development of validated assays for drugs and metabolites and use the latest equipment (LC-MS/MS, GC-MS, HPLC etc). TetraQ is also accredited to conduct ELISA assays.

ADME has a reputation for excellence in the analysis of drugs and metabolites in biological fluids. This includes "fit for purpose" assay development, depending on the stage of drug development.

We have well equipped world-class facilities that include:

• High performance liquid chromatography (HPLC) with a full range of detectors
• Gas chromatography-mass spectrometry (GC-MS)
• Liquid chromatograph-triple quadrupole mass spectrometry (LC-MS/MS) instrumentation (API2000 and 4000QTrap).
• ELISA instrumentation

We offer the following bioanalytical services:

• Method development
  • We can design an appropriate analytical method to measure your drug in biological fluids

• Validation

• Full validation to regulatory requirements, or reduced level of validation as appropriate

• Validated assays for >100 drug/metabolites currently in our database

• Analysis of drugs and/or metabolites
  • In a range of biological fluids
  • From in vivo or in vitro studies conducted in-house, or supplied to us from external sources
  • Able to handle large volumes of samples

• Toxicokinetics
  • Bioanalysis of samples (GLP Recogition)
    

• Pharmacokinetic (PK) studies
  • Dosing via intravenous, oral, subcutaneous, intraperitoneal or intramuscular routes. The accuracy and precision of these studies are designed to suit the stage of development and include common PK parameters (e.g., Cmax,Tmax, t1/2, AUC, Cl, Vd, F)

• Assessment of bioavailability
  • Following dosing by any of the above routes

• Toxicokinetic studies (GLP Recognition)

• Metabolism studies

• Including metabolite identification (mass spectral and/or following enzymatic incubations)

• Recovery of parent drug and/or metabolites in urine, feces or bile

• Tissue distribution studies
  • Including dosing with non-radiolabelled or radiolabelled versions of the investigational drug (supplied by the client)

In vitro ADME services

• Assessment of stability in a range of animal or human blood plasma
• Metabolic screening or profiling due to
  • Phase I (CYP450) or Phase II (glucuronidation) processes using microsomes, and
  • Phase II (sulfation) using S9, from livers of rats or humans (other organs and species possible)
• Identification of CYP450 isoforms responsible for metabolism
• Analysis of metabolism
• In cryopreserved human and rat hepatocytes (and other species)
  
  Metabolism Studies
  
• Microsomes and S9 used are from livers of Male Sprague-Dawley rats and pooled Mixed-sex humans Metabolism by individual human donors available if required.
  
  Using recombinant human CYPs
  
  Isolated perfused rat liver