Adr adverse drug reaction - Study guides, Class notes & Summaries

Adverse Drug Reaction (ADR) - CORRECT ANSWER In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Adverse Event (AE) - CORRECT ANSWER Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which ...

Medication Aide Pharmacology BasicsDEA - correct answer Drug Enforcement Administration federal agency regulates and enforces laws on drugs Schedule I-IV federal level schedule classification appropriate drugs FDA - correct answer Food Drug Administration federal agency determines manufacturer market its drug based on safety and efficiency data determines if generic drug therapeutically equivalent brand name drug ADR - correct answer Adverse Drug reaction chemical name - correct answe...

Adverse Drug Reaction (ADR) undesirable effects other than the intended therapeutic effect of a drug anaphylaxis severe reaction occurring immediately after exposure to a drug; characterized by respiratory distress and vascular collapse drug tolerance tendency of the body to become accustomed to a drug over time; larger doses are required to produce the desired effects half-life the amount of time it takes for half a dose of a drug to be eliminated from the body idiosyncratic effect ...

Active Error (or Active Failure) - ANSWER-An error that occurs at the point of contact. Active errors are generally readily apparent (e.g., pushing an incorrect button, ignoring a warning light) and almost always involve someone at the front line. Active failures are sometimes referred to as errors at the sharp end. Failures can be due to "latent" or system failures or can be due to "active" or human failures. Accreditation - ANSWER-One form of external review. The word technically mean...

absorption, distribution, metabolism, excretion - Answer-Pharmacokinetics involves absorption from the administration site either directly or indirectly in the blood plasma - AnswerPharmacokinetic absorption reversibly or irreversibly move from the bloodstream into the interstitial and intracellular fluid - Answer-Parmacokinetic distribution biotransformed via hepatic metabolism or by other tissue - Answer-Pharmacokinetics metabolism 1. highest bioavailability 2. places entire does into ve...

ACRP CCRC exam Questions and Answers 100% Correct The _________ has developed the Declaration of Helsinki (DoH): -Answer-World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. -Answer-the physician (DoH) In medical research, societal/scientific inter...

ACRP CCRC, CCRC Study Set Already Graded A+ ADR Adverse Drug Reaction Audit Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Brainpower Audit Certificate Confirmation audit took place Audit Report Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail Documentation of audit events Single Blind Study Subjects Unaware Double Blind Study ...

Adverse Drug Reaction (ADR) correct answers undesirable effects other than the intended therapeutic effect of a drug anaphylaxis correct answers severe reaction occurring immediately after exposure to a drug; characterized by respiratory distress and vascular collapse drug tolerance correct answers tendency of the body to become accustomed to a drug over time; larger doses are required to produce the desired effects half-life correct answers the amount of time it takes for half a dose o...

ADR - Adverse Drug Reaction Audit - Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Confirmation audit took place Audit Report - Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Documentation of audit events Single Blind Study - Subjects Unaware Double Blind Study - Subjects & Researchers are unaware

ACRP CCRC QUESTIONS AND ANSWERS 100% CORRECT ADR Correct Answer: Adverse Drug Reaction