Assessments of drug metabolism and pharmacokinetics (DMPK) are an essential part of drug discovery and development, providing researchers with key insights into in vivo drug behavior. The results can help determine which drug candidates warrant further therapeutic exploration (and which do not).
DMPK analysis of a drug candidate requires a detailed understanding of its adsorption, distribution, metabolism, and excretion (ADME) to fully evaluate its potential and determine specific formulation and dosing requirements. Given that DMPK analysis occurs throughout preclinical and clinical research, drug developers repeatedly require efficient DMPK/ADME testing to remain competitive and to avoid costly missteps in lead candidate selection and advancement.
Drug developers need to have confidence in their DMPK analysis. Avomeen’s bioanalytical laboratory can support drug discovery and development programs by designing and executing DMPK analysis and ADME assays. Our clients benefit from a host of available in vitro ADME assays, custom method development, and our ability to rapidly test preclinical and clinical samples. With rapid turnaround times, we get your data back faster without sacrificing thoroughness or quality.
From selecting a candidate with an appropriate ADME profile to monitoring its bioavailability throughout clinical trials, Avomeen’s team serves as a true partner and full-service DMPK CRO.
DMPK Analysis & ADME Services
Regardless of whether your drug candidates are small molecules or biologics, Avomeen is equipped to track your candidates’ pharmacokinetics and metabolism.
Part of Avomeen’s bioanalytical speed comes from well-established in vitro ADME assays that can be readily adapted to specific drug candidates. Using these methods, Avomeen can evaluate dosage regiments, compare administration routes, and perform basic safety assessments on animal model samples supplied by our pharmaceutical partners. These essential analyses can help jumpstart progress by providing an early glimpse at the candidate’s DMPK behavior and supporting IND-submissions.
If a more specific or refined experimental approach is required, Avomeen can readily design and develop a novel DMPK/ADME assay method. Our partners can then choose whether they’d like to transfer this method elsewhere, such as to internal sites, or have Avomeen execute sample analysis directly. Either way, our bioanalytical team will ensure that the method is quickly activated, so sample analysis can begin without delay.
While many ADME assays are based on immunoassays and ELISAs, Avomeen’s DMPK/ADME expertise extends to a broad collection of analytical techniques. Avomeen can also fully integrate these ADME assessments with our toxicity services to provide a full framework for DMPK-toxicology studies. Leveraging our vast skillset and instrument collection, we can develop and execute nearly any experimental request.
With all methods in hand, Avomeen can serve as your DMPK lab, testing bioavailability and drug metabolism throughout your clinical research. It’s as simple as sending your animal or human samples to Avomeen; our bioanalytical laboratory will do the rest — saving precious time and internal lab resources, which you can devote elsewhere.
Therapeutic Drug Monitoring (TDM)
In addition to more routine bioavailability analysis, some drugs under investigation require therapeutic drug monitoring (TDM), which more closely tracks drug concentrations in patients. Drug candidates requiring TDM have a particularly narrow therapeutic index. This means that small variations in dose or concentration can lead to therapeutic failures or harmful side effects. With TDM, patient samples must be routinely and rapidly tested to ensure drug levels are neither too high nor too low.
Processes Involved in Drug Handling and Therapeutic Drug Monitoring
Knowing the risks associated with drugs that require TDM, Avomeen’s DMPK Lab has built high-throughput capacity and accelerated workflows to keep up with TDM result demand throughout the course of your trial. Leaning on our promise to deliver efficient turnaround times and quality reporting, clients can trust Avomeen to regularly measure drug concentrations in serum or plasma to ensure drug effectiveness and subject safety.