SMALL MOLECULE SERVICES

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

  Today choosing the right nonclinical test system can help sponsors get their product through the approval process more efficiently by reducing the amount of clinical testing required. Absorption Systems provides […]

• Drug Transporter Testing Services

  Absorption Systems has extensive experience evaluating the potential interactions of compounds with drug transporter proteins. We follow the latest recommendations and guidelines from the FDA and EMA. The Absorption Systems […]

• 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 […]

• Metabolism Assay Services

  Importance of studying drug metabolism A drug candidate encounters a large variety of enzymes in the liver such as p450s and UGTs These enzymes transform the drug into active or […]

• Permeability Assay Services

  Cell-Based Absorption Systems offers different cell lines such as Caco-2, MDCK-MDR1 which are well-established tools for predicting intestinal absorption of drug candidates. Advantages of cell monolayers: Established, robust in-vitro models, […]

• Physicochemical Properties and Dose Selection

  Physicochemical Property Testing Solubility Assessment (bio-buffers and formulation excipients) Dissolution Testing Chemical Stability LogD Assessment Dose Vehicle Development & Evaluation: Excipient Selection API – Compatibility Vehicle – Suitability Stability (dose […]

• Preclinical Pharmacokinetics 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 formulation to PK parameters.  With the convenience […]

• Preclinical Toxicology Testing Services

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

• 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 […]