Our Drug Metabolism and Pharmacokinetics department offers a full and comprehensive service for both in vitro and in vivo studies in support of IND, CTA and NDA submissions. We can evaluate the metabolic and pharmacokinetic characteristics of pharmaceutical and biotechnology compounds and provide you with a range of customized services to characterize ADME properties of synthetic and biotechnology compounds. Our laboratories are GLP accredited, and our work is analyzed and reported in accordance with GLP, GCP, GCLP, and relevant ICH, EMEA, and FDA guidelines, as appropriate.
We provide our clients with:
- Quality - services are preformed to international standards of science and quality.
- Flexibility - we offer quick start dates and timely delivery of quality data.
- Experience - our employees offer a wealth of experience and can help you define the best strategy for the development of your compound.
- Focus - we provide resources and know-how to drive your ultimate goal – getting to market faster.
Whether you are at a drug discovery, preclinical, or clinical development stage, our services can be tailored to your requirements and we can assist you with:
- Non-Clinical Pharmacokinetics – Toxicokinetics and pharmacokinetics to support toxicology studies. Interspecies scaling.
- ADME Studies – Pharmacokinetics, mass balance, tissue distribution, plasma protein binding and blood cell binding.
- Metabolite Profiling and Identification - Metabolite profiling and identification using our samples from mass balance and PK studies (animal and human).
- In Vitro Studies - Metabolic stability, interspecies profiling, inhibition, induction, isozyme characterization, drug-drug interactions.
- Human Radiolabelled Trials - Dosimetry calculations to determine safe radioactive dose level for healthy volunteers. Analysis of human radiolabelled samples.
- Pharmacodynamics and PK/PD Modelling - Applicable in support of pharmacology studies as well as the clinical setting.
- Clinical Pharmacokinetics and Biostatistics - Analyzing and reporting pharmacokinetics in clinical trials from Phase I through to proof of concept.