Our NDA-enabling portfolio of preclinical drug discovery and drug development services includes rigorous and definitive assays in all areas of ADMET, often triggered by specific requests from a regulatory agency. We have an extensive history of performing late-stage studies to support successful NDA submissions, mainly related to toxicology or drug-drug interactions. Our philosophy of utilizing the same validated in vitro test systems across the board, with different levels of rigor, ensures that results will be consistent from screening through NDA.

Drug Discovery & Development Services

  • Bioanalytical Testing Services

    Navigating regulatory requirements for bioanalytical testing can be challenging and time-consuming. Absorption Systems’ bioanalytical experts will provide you with complete study support, from custom method development through validation and sample […]

  • Bioequivalence Testing

    Bioequivalence testing is critical to gain regulatory approval for non-NDA submissions. Choosing the right nonclinical test system can help sponsors get their product through the approval process more efficiently by […]

  • Drug Transporter Testing Services

    Transporters are membrane-bound proteins that enable movement of substances, from nutrients to xenobiotics, in and out of cells. Drug transporter interactions are an important part of the pharmacokinetic properties of […]

  • In Vitro Dissolution Absorption System (IDAS)

    The In Vitro Dissolution Absorption System (IDASTM) combines traditional dissolution testing with a means to determine and quantify interactions with a bio-relevant membrane. The characterized and validated system allows for multiple dissolution […]

  • Metabolism Assay Services

    Metabolism is an important determinant of oral bioavailability, clearance, and half-life of drug products in vivo. The metabolic pathway of your drug also has important implications for drug-drug interactions.  Understanding […]

  • Permeability Assay Services

    Permeability assays can enable accurate predictions of in vivo bioavailability, and are crucial for classification of drugs based on Biological Classification System. Leveraging these studies properly can inform development and streamline regulatory […]

  • Physicochemical Properties and Dose Selection

    Understanding the physiochemical properties of your drug are prerequisites to accurate assessments of dose selection. We specialise in using robust, established assays, combined with our expertise, to help you understand […]

  • Preclinical Pharmacokinetics Testing Services

    Understanding the pharmacokinetics of your compound is essential at all stages of the development process. Speed and flexibility is often of critical importance to enable you to make informed, data-driven […]

  • Preclinical Toxicology Testing Services

    Preclinical toxicology and related safety studies are a pivotal part of the drug development life cycle. They are needed to demonstrate that the test compound is safe, and at what […]

  • Protein and Tissue Binding

    Protein and tissue binding studies allow prediction of in vivo drug concentration in blood, identify appropriate fluid medium for pharmacokinetic studies, and help determine the extent of distribution of a […]

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