Glossary

Contract Development and Manufacturing Organization (CDMO)

02.27.12

A company that offers both contract drug development and manufacturing services. Comprehensive services range from early-stage R&D services such as synthesis, scale-up, formulation development, stability studies and method development all the way through manufacturing services, ranging from preclinical R&D material for clinical trial purposes and commercial production (Phases I-IV).
  • Contract Manufacturing Organization (CMO)

    A company that offers manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trials purposes and commercialization.…
    02.27.12

  • International Conference on Harmonization (ICH)

    Full name: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH brings together the regulatory authorities of Europe, Japan and the U.S. and experts from the pharmaceutical ind…
    02.27.12

  • Pharmacogenomics

    The application of genomics to the discovery and development process for drugs. This use of genetic information can predict the safety, toxicity and/or efficacy of drugs in individual patients or groups of patients. Genomics may aid drug development…
    02.27.12

  • Proteomics

    The study of gene expression at the protein level, by the identifying and characterizing proteins present in a biological sample. By comparing samples from healthy and diseased tissues, it is possible to identify proteins that are specific to disease…
    02.27.12