FDA Guidelines Flashcards
What is an ARfD
Acute Reference Dose. An estimate of the amount of residues expressed on a body weight basis that can be ingested in a period of 24 h or less without adverse effects or harm to the health of the human consumer.
What is an ADI?
Acceptable Daily Intake is the daily intake which, during up to an entire life of a human, appears to be without adverse effects or harm to the health of the consumer. The ADI most often will be set on the basis of the drug’s toxicological, microbiological, or pharmacological properties. It is usually expressed in micrograms or milligrams of the chemical per kilogram of body weight per day.
What is a BMD?
Benchmark Dose. A dose of a substance associated with a specified low incidence of response, generally in the range of 1 to 10%, of a health effect, or a dose associated with a specified measure or change of a biological effect.
What is a BMDL?
Benchmark Dose Lower Confidence Limit. A dose producing an appropriate, low, and measurable response at a defined lower bound response level based on the lower one9 Contains Non-Binding Recommendations sided confidence limit of a 95% confidence interval extrapolated from a line fitted to available data for an appropriate endpoint.
What is the EHC?
Environmental Health Criteria. International Program on Chemical Safety (IPCS) documents that provide international critical reviews on the effects on human health and the environment of chemicals or combinations of chemicals, including veterinary drugs, as well as physical and biological agents.
What is the IPCS?
International Program on Chemical Safety. A joint program of the World Health Organization, International Labor Organization and the United Nations Environment Programme.
What is does OECD stand for?
Organization for Economic Co-operation and Development brings together the governments of various countries to support sustainable economic growth, boost employment, raise living standards, maintain financial stability, assist other countries’ economic development and contribute to world trade.
What does QSAR stand for?
Quantitative Structure Activity Relationship. A quantitative relationship between a biological activity (e.g., toxicity) and one or more molecular descriptions that are used to predict activity.
