SciScout, headquartered within minutes of Research Triangle Park, NC, provides life sciences consulting services to companies within the pharmaceutical, chemical and related industries.
TOXICOLOGY ASSESSMENT SERVICES
SciScout is contracted by pharmaceutical, biotechnology and related companies to produce study reports assessing possible toxicity and human health risk of chemical contaminants and other impurities associated with their products. Our clients submit our detailed study reports along with other documents as part of their regulatory submission process. We develop our toxicology assessment reports from an extensive search and review of the scientific literature, accessible databases and use of analytical data for extractables, leachables, particles or other product-associated contaminants provided by our clients. We apply structure-activity relationships (SAR) and other comparative methods to assist in assessments when available toxicology literature is limited for some compounds. Reference Doses (RfDs) and Acceptable Daily Intakes (ADIs) of compounds are computed from No Observed Adverse Effect Levels (NOAELs). Patient exposure length, administration route and patient population are all considered when assessing possible toxicity and human health risk.