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Design. Performance. Interpretation.

Using the best science to identify and overcome ADMET barriers in the development of drugs, biologics and medical devices

Continually developing innovative research tools to accurately predict human outcomes and explain unanticipated ones

Preclinical testing that delivers what the FDA demands

  • IND- and NDA-enabling services
  • Optimized and validated test systems
  • Trustworthy and reproducible data
  • Comprehensive support for testing and analysis
  • Consultative collaboration

Reliable and quick animal PK data with predefined or custom protocols

  • Multiple species and dose routes available
  • GLP chronic and sub-chronic tox studies
  • Complementary dose vehicle development and bioanalysis

State-of-the-art, cutting edge science for understanding drug transporters

  • Providing clarity with superior cell lines
  • The most definitive assay systems in the industry
  • In vitro studies to enable waivers of clinical drug interaction studies
  • A decade of experience submitting in vitro,
    cell-based permeability data to the FDA

Bypass expensive and time-consuming clinical bioequivalence studies

  • Easy 3 steps to BCS
  • Permeability classification at the lowest available threshold
  • Audited FDA-ready reports
  • Leader in BCS classification studies

Services, experimental models, and surgical capabilities to enable preclinical medical device testing and physician training

  • Orthopedic and cardiovascular implants
  • Drug delivery devices
  • Devices for wound healing
  • Ophthalmology
  • Tissue engineering
  • General surgery

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Literature

In Vitro Drug Safety: The Safety Suite
A comprehensive package of in vitro drug-drug interaction and other safety-related tests
CellPort Portfolio of Services

More Literature »

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