Glossary

Contract Manufacturing Organization (CMO)

02.27.12

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.
  • Clinical Trials

    Carefully designed investigations of the effects of investigational new drugs, medical treatments, or devices on a group of patients. There are typically three phases of clinical trials prior to the filing of an NDA, sometimes followed by ongoing, po…
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  • Endpoint

    In clinical trials, a parameter used to compare the results in different arms of the trial. Endpoints may be directly related to the condition (such as progression of the disease) or may be measurements of surrogate markers.…
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  • 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…
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  • Investigational New Drug Application (IND)

    An application to the FDA to begin clinical trials of a new drug or biologic on humans. The IND gives the plan for the study and contains formulation, manufacturing and animal test result information.…
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  • Lead Compound

    A peptide or small molecule that can bind to a target and bring about a therapeutic effect. A successful lead compound will become a drug candidate for clinical trials. See Derivative.…
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  • New Drug Application (NDA)

    An application to FDA for a license to market a new drug in the U.S. Sponsor companies submit NDAs after completing clinical trials on a new drug.…
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  • Placebo

    A dosage form not containing the active drug given, for example, in clinical trials to the control group to differentiate the drug effect from the psychological effect of treatment.…
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  • Data and Safety Monitoring Board (DSMB)

    A group of researchers who periodically review data from blinded, placebo-controlled clinical trials. A DSMB board can stop a trial if toxicities are found or if the treatment is proved beneficial.…
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  • Electronic Data Capture (EDC)

    Collection of data in an electronic format, typically used in reference to data obtained from clinical trials.…
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  • Contract Development and Manufacturing Organization (CDMO)

    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 thr…
    02.27.12