signal definition review

1 year ago 70
Nature

Signal has different meanings depending on the context. Here are the definitions of signal in different contexts:

Signal in Pharmacovigilance:

  • A safety signal is an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known.
  • Signal detection is the process of looking for and identifying signals from any available source. Sources for signals include reviews of ICSRs, aggregated data, new studies, and scientific literature. Once a signal is detected, it must be validated to determine if there is sufficient evidence in the available data for further investigation of the safety signal.

Signal in Pesticide Products:

  • Signal words are found on pesticide product labels, and they describe the acute (short-term) toxicity of the formulated pesticide product. The signal word can be either: DANGER, WARNING, or CAUTION. Products with the DANGER signal word are the most toxic, while products with the signal word CAUTION are lower in toxicity. The U.S. Environmental Protection Agency (EPA) requires a signal word on most pesticide product labels.

Signal in Safety Data Sheets (SDS):

  • In SDS, signal refers to the classification of a hazardous product. Each ingredient in the mixture must be listed when it is classified in a health hazard class and is present above the concentration limit that is designated for the hazard class in which it is classified or is present in the mixture at a concentration that results in the mixture being classified in any health hazard class.

In summary, signal can refer to a safety-related data for a marketed product, acute toxicity of pesticide products, or classification of a hazardous product in SDS.