Drug Metabolism and Pharmacokinetics
Our Drug Metabolism and Pharmacokinetics department offers a full and comprehensive service to evaluate and optimize the Absorption, Distribution, Metabolism and Elimination (ADME) and pharmacokinetic (PK) properties of potential drugs from early discovery projects through to IND, CTA and NDA submission.
We provide solutions to assist in candidate advancement challenges through integration of all relevant information in order to make the very best decisions possible.
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 to interpret the data and define the best strategy for the optimization of your lead molecule or for the development of your compound.
- Focus - we provide resources and know-how to drive your ultimate goal – getting to market faster.
- Integration - we offer packages of studies integrated within all the involved disciplines
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:
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Non-Clinical Pharmacokinetics – Customised pharmacokinetics to support Lead Optimization, Toxicokinetics and pharmacokinetics studies. Interspecies evaluation and scaling.
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ADME Studies – Pharmacokinetics, mass balance, tissue distribution, plasma protein binding and blood cell binding.
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Metabolite Profiling and Identification - Metabolite profiling and identification using our samples from mass balance and TK/PK studies (animal and human). MIST, fast metabolite identification and cross-species characterization using high resolution
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In Vitro Studies - Metabolic stability, tissue binding and distribution, interspecies profiling, preliminary and definative (BCS) permeability, inhibition, induction, substrate properties characterization for enzymes and transporters, drug-drug interactions and bio-activation potential and bio-synthesis of active metabolites and new chemotypes.
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Human Radiolabelled Trials - Dosimetry calculations to determine safe radioactive dose level for healthy volunteers. Analysis of human radiolabelled samples.
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Pharmacodynamics and PK/PD Modelling - Applicable in support of pharmacology studies as well as the clinical setting.
Our reports are comprehensive and concise with data presentation (tabular and graphical) designed to clearly answer the objectives of the study. An independent audit of the draft report and associated data are routinely performed by our Aptuit Quality Group unless specified otherwise.
Our work is analyzed and reported in accordance with GLP and relevant ICH, EMEA, and FDA guidelines, as appropriate.