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

    Screening to Fully Validated GLP Bioanalysis Our bioanalytical services expertise provides quantitative measurements on a range of active drugs, from small molecules to peptides, as well as metabolites. We can perform […]

  • In Vitro Dissolution Absorption System (IDAS)

    Biopharmaceutics dissolution with better in vivo correlation The In Vitro Dissolution Absorption System (IDASTM) combines traditional dissolution testing with a means to determine and quantify interactions with a bio-relevant membrane. IDAS provides […]

  • Transporters

    Why evaluate the substrate and inhibitor potential of the investigational drug for specific transporters and why do the FDA and EMA care? Membrane transporters can have clinically relevant effects on […]

  • Physicochemical Properties and Dose Selection

    Solubility Assessment (bio-buffers and formulation excipients) Dissolution Testing Chemical Stability Dose Vehicle Development & Evaluation: Excipient Selection API – Compatibility Vehicle – Suitability Stability (dose vehicle) Artificial Fluids Interactions Simulated […]

  • Pharmacokinetics

    Complete study support from formulation to PK parameters. Rapid turnaround to support drug discovery. Experienced team with more than 30 years supporting DMPK. End to End In-life with Bioanlaytical Support. […]

  • Metabolism

    Metabolism is the enzymatic modification of drugs and other xenobiotics, usually to increase clearance. It is a determinant of oral bioavailability, clearance, and half-life in vivo. Metabolism occurs predominantly in the […]

  • 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 […]

  • Permeability

    Cell-Based Different cell lines (e.g., Caco-2 clone C2BBe1, MDR1-MDCK, MDCK, BCRP-MDCK) are used as in vitro models for different purposes. Caco-2 cell monolayers predict not only intestinal absorption but also drug-drug […]

  • Preclinical Toxicology Services

    Start your safety and tox program with a strong strategy that anticipates issues and avoids costly delays. From pharmacokinetics through safety/tox assessments, Absorption Systems has the experience and accredited resources […]

  • Drug Delivery Services

    View our extensive capabilities within Preclinical Drug Delivery services. We provide a complete pharmacokinetic evaluation for each study. Formulation Dissolution and/or Release Characterization Transdermal Patches / Creams / Ointments Buccal […]

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