Element offers a wide range of ADME and DMPK laboratory services, and can accept both in vivo and in vitro samples, providing researchers with critical insights into drug behavior, enabling data-driven decisions regarding which drug candidates are the most viable for further therapeutic exploration.
Adsorption, distribution, metabolism, and excretion (ADME) and drug metabolism and pharmacokinetics (DMPK) analysis is a critical component of drug discovery and development, as ADME and DMPK studies of drug candidates allow drug developers to fully evaluate the potential of a specific formulation and determine dosing requirements. Assessments of drug metabolism and pharmacokinetics are essential, as they provide researchers with key insights into in vivo drug behavior. The results of these studies can help drug developers help determine which drug candidates warrant further therapeutic exploration, and which do not. Provided that DMPK analysis takes place throughout preclinical and clinical research, drug developers repeatedly require efficient DMPK/ADME testing to remain competitive and avoid costly missteps in lead candidate selection and advancement.
Element’s bioanalytical laboratory supports drug discovery and development programs by designing and executing DMPK analysis and ADME assays. In addition to a host of available in vitro ADME assays, Element’s customers benefit from custom method development and a steadfast commitment to high quality, thorough, and swift testing of preclinical and clinical samples. Get your data back faster without sacrificing thoroughness or quality with our rapid turnaround times. Well-established in vitro ADME assays that can be readily adapted to specific drug candidates enable Element’s bioanalytical speed. Using these methods, our scientists can evaluate dosage regiments, compare administration routes, and perform basic safety assessments on animal model samples supplied by our pharmaceutical partners. Jumpstart progress with these essential analyses, getting an early glimpse at the candidate’s DMPK behavior and supporting IND-submissions.
Element can also readily design and develop novel DMPK/ADME assay methods if a more specific or refined experimental approach is required. Methods can then be transferred elsewhere, such as to internal sites, or Element can execute sample analysis. In either scenario, our bioanalytical team will ensure that the method is quickly activated, avoiding any delays in sample analysis.
Full-service ADME and DMPK CRO
As a full-service DMPK contract research organization (CRO), Element’s purpose-built labs and teams of consultative, accessible scientists serve as a true partner throughout the entire drug development life cycle, from drug candidate selection to monitoring bioavailability throughout clinical trials. Our ADME and DMPK expertise extends well beyond typical assay development, which usually employs enzyme-linked immunosorbent assay (ELISA) and immunoassay platforms; instead, our scientific experts use a broad collection of analytical techniques. These ADME assessments can also be fully integrated with our toxicity services, providing a full framework for DMPK-toxicology studies.
Element is well-equipped to track drug candidates’ pharmacokinetics and metabolism for both small molecules and biologics. With all methods in hand, Element can serve as your DMPK lab, testing bioavailability and drug metabolism throughout clinical research. Just send your animal or human samples to Element, and our bioanalytical laboratory will do the rest, saving precious time and internal lab resources, which can be devoted elsewhere.
DMPK analysis & ADME services
- Novel DMPKE/ADME assay development and validation
- DMPK-toxicology studies when integrated with toxicity services
- DMPK & ADME method transfer and sample analysis
- High throughput therapeutic drug monitoring (TDM)
Therapeutic drug monitoring (TDM)
Some drugs under investigation call for therapeutic drug monitoring (TDM) to closely track drug concentrations in patients, in addition to more routine bioavailability analysis. Drug candidates with an especially narrow therapeutic index require TDM, as therapeutic failures or harmful side effects can result from slight variations in dose or concentration. With TDM, patient samples must be routinely and rapidly tested to ensure drug levels are neither too high nor too low.
We understand the risks associated with drugs that require TDM. For that reason, Element’s DMPK Lab has built high-throughput capacity and accelerated workflows to keep up with TDM result demand throughout the course of clinical trials. Leaning on our promise to deliver efficient turnaround times and quality reporting, leading drug developers and biopharmaceutical organizations trust Element to regularly measure drug concentrations in serum or plasma to ensure drug effectiveness and subject safety.
The Element advantage
Element’s dedicated team of industry-leading scientific experts offer a wide range of innovative ADME and DMPK solutions and services for early and late-stage discovery programs, customized to meet specific customer requirements. Our team is ready to partner with you, providing the highest quality ADME and DMPK services to help validate toxicology studies, support safety evaluations, and indicate the likelihood of drug-drug interactions.
For more information about our ADME and DMPK lab testing services or to request a quote, contact us today.
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