Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 12

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment (ICH E2A).

Any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of any dose of a medicinal product, whether or not considered related to the medicinal product (ICH E2A).

Table 1. Selected Initialisms and Acronyms Used in this Manual

Initialism	Interpretation
AE	Adverse Event, sometimes Adverse Drug Event (ADE) or, for FDA, also means Adverse Experience
API	Active Pharmaceutical Ingredient
AR	Adverse Reaction, sometimes Adverse Drug Reaction (ADR)
CCSI	Company Core Safety Information
CFR	Code of Federal Regulations, for US
DCSI	Development Core Safety Information
GVP	Good Pharmacovigilance Practice, for Post-marketing in the EU
ICH	International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (formerly International Conference on Harmonization)
IME	Important Medical Event
SAE	Serious Adverse Event
SAR	Suspected Adverse Reaction, sometimes Serious Adverse Reaction
SADR	Serious Adverse Drug Reaction, sometimes Suspected Adverse Drug Reaction, neither of which is currently in common use
SUSAR	Serious Unexpected Suspected Adverse Reaction, used in the EU trials and outside the US; similar in concept to FDA’s Suspected Unexpected Serious Adverse Reaction (no initialism for FDA)
NSAE	Non-serious Adverse Event
NSAR	Non-serious Adverse Reaction