Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Herbal Products: Medicinal products containing, exclusively, plant material and/or vegetable drug preparations as active ingredients. In some traditions, materials of inorganic or animal origin can also be present.

IARC: International Agency for Research on Cancer.

Inhalation Unit Risk: The upper-bound excess lifetime cancer risk estimated to result from continuous exposure to an agent at a concentration of 1 µg/L in water, or 1 µg/m 3 in air. The interpretation of inhalation unit risk would be as follows: if unit risk = 2 x 10 -6 per µg/L, 2 excess cancer cases (upper bound estimate) are expected to develop per 1,000,000 people if exposed daily for a lifetime to 1 µg of the chemical in 1 liter of drinking water. (US EPA)

IPCS: International Programme for Chemical Safety. IUPAC: International Union of Pure and Applied Chemistry.

IRIS: Integrated Risk Identification System, United States Environmental Protection Agency. LOAEL: Lowest-Observed-Adverse-Effect Level: Lowest concentration or amount of a substance (dose) , found by experiment or observation, that causes an adverse effect on morphology, functional capacity, growth, development, or life span of a target organism distinguishable from normal (control) organisms of the same species and strain under defined conditions of exposure . (IUPAC) LoQ : Limit of Quantitation: The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. (ICH Q2) LOEL: Lowest-Observed-Effect Level: The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals. Modifying Factor: An individual factor determined by professional judgment of a toxicologist and applied to bioassay data to relate that data to human safety. (ICH Q3C) (See related term Safety Factor) MRL: Minimal Risk Level: An estimate of the daily human exposure to a hazardous substance that is likely to be without appreciable risk. (ATSDR)

NAS: National Academy of Science. (USA)

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