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•Long, costly, and inherently risky: only 1 of 10-15,000 reach FDA approval • Toxicology testing is required to demonstrate that drugs are safe before they can be given to humans Why do Toxicology Testing?
Exposure Effect Efficacy Toxicity Desired Efficacy (eg ED 90) Acceptable Toxicity (Normally the ‘ No observed adverse effect level ’ or NOAEL)
Chemistry and Toxicology Guide for Specimen Acceptability and Add-on Requests Test Name Acceptable Tube Types Specimen Received UNSEPARATED (UNSPUN) Specimen ADD-ON Received (Aliquoted SEPARATED plasma/serum or (Aliquoted spun SST/PST) plasma/serum or Specimen uncapped Spun SST/PST) at RT for up to 8hr Kept cool during then stored
WHY DOES IT TAKE SO LONG? By Jeff Eitner, Springfield Lab In this Issue: • Toxicology Results Timelines Explained • Collection of Blood and Urine Samples for Tox Testing • New Opioid Drugs Implicated in Oregon Deaths • A New Tox Instrument Promises Improved Analysis • Tox Top 24: 2016 vs 2011 OREGON STATE POLICE