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NIA Adverse Event and Serious …
- https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf
Adverse event - Wikipedia
- https://en.wikipedia.org/wiki/Adverse_event
- An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
- The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether …
Untoward Definition & Meaning - Merriam-Webster
- https://www.merriam-webster.com/dictionary/untoward
- un· to· ward ˌən-ˈtō-ərd -ˈtȯ (-ə)rd; ˌən-tə-ˈwȯrd Synonyms of untoward 1 : difficult to guide, manage, or work with : unruly, intractable 2 a : marked by trouble or unhappiness : …
ICH GCP - 1. GLOSSARY
- https://ichgcp.net/1-glossary
- 1. GLOSSARY. 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose (s) …
5. Terms, Definitions and Examples for Adverse Event …
- https://allaboutpharmacovigilance.org/5-terms-definitions-and-examples-for-adverse-event-reporting/
- 1. Abortion, miscarriage or uterine hemorrhage associated with misoprostol (Cytotec), a Labor-inducing drug (this is a case where the adverse effect has been used …
Untoward - definition of untoward by The Free Dictionary
- https://www.thefreedictionary.com/untoward
- untoward. ( ˌʌntəˈwɔːd; ʌnˈtəʊəd) adj. 1. characterized by misfortune, disaster, or annoyance. 2. not auspicious; adverse; unfavourable. 3. unseemly or improper. 4. out of …
Untoward Definition & Meaning | Dictionary.com
- https://www.dictionary.com/browse/untoward
- untoward / ( ˌʌntəˈwɔːd, ʌnˈtəʊəd) / adjective characterized by misfortune, disaster, or annoyance not auspicious; adverse; unfavourable unseemly or improper out of the …
Untoward incident | definition of untoward incident by …
- https://medical-dictionary.thefreedictionary.com/untoward+incident
- untoward incident An NHS (UK) term for any event, incident, occurrence or accident, which could have or did lead to unintended harm, loss or damage to a patient, visitor or member …
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