Glossary

Contract Research Organization (CRO)

02.27.12

A company involved in performing non-clinical or clinical research on a contract basis for a pharmaceutical or Biotech company, research organization, or other health organization. For non-clinical CROs, studies or full programs are contracted by the sponsor, and may include early discovery screening tudies, Toxicology, Safety Pharmacology, Genetic Toxicology, Bioanalytical assays, Drug Metabolism and Pharmacokinetic studies. For clincal CROs, the outsourced work may include enrolling patients, writing the protocol, conducting and monitoring the trial, running analytical lab tests or bioanalytical assays, performing statistical analysis, and writing the report and regulatory submission documents.
  • No Observed Adverse Effect Level (NOAEL)

    A dose in toxicology studies that produces no adverse effects.…
    03.25.13

  • ADME/T

    See Absorption, Distribution, Metabolism and Excretion/ Toxicology.…
    02.27.12

  • Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T)

    The objective of ADME/T testing is to measure what happens to a compound in the human physiology. ADME/T tests are done during the preclinical stage of the drug discovery process and are a necessary part of any clinical trial, prior to filing an IND.…
    02.27.12