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Clinical Pharmacology Modeling SimulationDrug metabolism and pharmacokinetics (DMPK) is an essential part of drug discovery and development. A central role of DMPK is to help optimize new molecular entities (NME) in Discovery, including small molecules and biologics, by assessing their absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic (PK) properties. Similar to DMPK studies, nonclinical pharmacodynamic (PD) studies use relevant in vitro and in vivo models of disease to provide valuable information about the potential efficacy profile of candidate therapeutics.
Understanding these properties helps drug developers identify key features and potential risks such as drug-drug interactions (DDIs), off-target effects, or immunogenicity for optimization and mitigation, thereby ensuring that the best possible candidates are advanced into clinical development. Although in-depth nonclinical DMPK and PD evaluation can improve the probability of success for new drug candidates, new therapies in early clinical trials routinely fail due to sub-optimal ADME, PK, and PD properties. This emphasizes the central importance of a robust nonclinical study strategy within the Discovery phase, not only in selecting the best candidates for clinical development but also because it generates data that are critical in predicting likely outcomes in humans.
There has been tremendous progress in technology platforms and biosimulation techniques that enable the application of model-informed drug discovery and development approaches, such as physiologically based PK (PBPK), quantitative systems pharmacology (QSP), and quantitative systems toxicology (QST) modeling. The net result is that ADME, PK, and PD data are effectively translated into meaningful and interpretable clinical outcomes that provide a greater quantitative understanding of candidate attributes to enable more informed, timely, and effective decision-making.
DMPK and Translational Discovery and Development Services
Allucent’s scientists have drug discovery experience and expertise to help plan and execute your program’s DMPK screening funnels, studies, clinical translation, and development strategy. Learn more about how Allucent can help support your early drug discovery and development programs with our DMPK and translational discovery services including: