Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 14

The FDA uses the term adverse event/experience and defines it as follows:

For post-marketing cases: Any AE associated with the use of a drug in humans, whether or not considered drug-related, including the following: An AE occurring in the case of the use of a drug product in professional practice; an AE occurring from drug overdose whether accidental or intentional; an AE occurring from drug abuse; an AE occurring from drug withdrawal; and any failure of expected pharmacological action (21CFR314.80(a)).

For clinical trial cases: Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. In practice, most people use the term “AE” to refer to any “bad thing” that occurs during the use of a drug without implying that the bad thing is due to the drug. The bad thing may be due to the drug substance, excipients, packaging, storage issues or other problems and may or may not be due to the active ingredient.