Dedicated to providing top quality, specialist bioanalysis and pharmacokinetic analysis services at every stage of the product development cycle from discovery to pivotal clinical studies.
This page is dedicated to GCP/GMP bioanalysis and pharmacokinetic analysis for small and large molecules. For analysis of large molecule biopharmaceutical products click here.
Almac has the ability to provide both bioanalysis and PK data on an interim basis enabling our clients to make decisions on a continuous basis. This is particularly useful at the Proof of Concept phase or Dose Escalation studies where the pharmacokinetic data is often crucial to making important safety decisions regarding dosing.
Our team is committed to working with our clients to fully understand their projects and ultimate objectives and we are equally committed to small standalone bioanalysis projects as well as large projects, where we coordinate all activities from protocol development, CRO selection, in house bioanalysis, PK to integrated ICH report.
Our department combines a depth of experience and expertise with a unique and flexible approach, treating each project separately and providing solutions that are appropriate to the stage of the project and to the clients specific needs. We have 4 study directors at Almac each with >20 years’ experience in the field.
- GLP method development & validation
- Mass Spectrometry
- Bioanalysis in multiple matrices
- Non GLP drug discovery
- Pre-clinical toxicokinetic analysis
- Bioavailability & bioequivalence studies
- Preclinical, Phase 1-4 support
- Biomarkers analysis
- Non-compartmental and compartmental pharmacokinetic analysis
- Bioavailability and bioequivalence studies
- Preclinical toxicokinetic analysis
- PK/TK study design, protocol development and drug disposition consultancy
- Guidance on scaling from animals to humans
- In Vitro in vivo correlations
We have validated hundreds of assays across all therapeutic areas and classes of drugs. For a full list of our proprietary assays click here.