Historical Events
This study involved withholding penicillin form Black men with syphilis for decades.
What is the Tuskegee Syphilis Study?
This regulatory agency is responsible for approving drugs and biologics in the U.S.
What is the FDA (Food and Drug Administration)?
The term for harmful, unintended effects of a medication.
What is adverse drug reaction?
The suffix "-itis" indicates this condition.
What is inflammation?
"Patient has high blood pressure"
What is hypertension?
In 2006, healthy volunteers in the U.K. suffered organ failure within hours of dosing in this trial.
What is the TGN1412 trial?
This U.K. authority tightened rules on early-phase trials after the TGN1412 disaster.
What is the Medicines and Healthcare products Regulatory Agency (MHRA)?
Drugs like propranolol, metoprolol, and practolol are this class/type of medication.
What are beta blocker (antihypertensives)?
The term "hypothermic" refer to..
What is low temperature (below desired temperature)?
"Patient experienced a heart attack."
What is a myocardial infarction?
What is the Sulfanilamide Elixir Disaster?
This EU-wide body coordinates drug safety reports across member territories.
What is the European Medicines Agency (EMA)?
This is the study of how drugs move through the body (absorption, distribution, metabolism, excretion).
What is pharmacokinetics?
The combining form "hemat/o" refers to this in the body.
What is blood?
"Patient developed sudden shortness of breath and difficulty breathing."
What is dyspnea?
This sedative caused birth defects in infants in the 1950s-60s.
What is Thalidomide?
What is the World Health Organization (WHO)?
Proton pump inhibitors, like omeprazole, work by reducing the production of this substance in the body.
What is gastric acid?
The term "hepatomegaly" refers to....
What is enlargement of the liver?
"Yellowing of the eyes and skin."
What is jaundice?
This arthritis drug was withdrawn globally in 2004 after heart risks emerged.
What is Vioxx?
A sponsor identifies a serious adverse event during a multinational trial. The FDA, EMA, and MHRA all must be notified. Which global body helps harmonize reporting standards across these agencies?
What is ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)?
A patient develops a persistent dry cough after starting a new medication for high blood pressure. What class of drug most likely caused the cough?
What are ACE inhibitors (angiotensin-converting enzyme inhibitors)?
This term refers to deficiency of platelets in the blood.
What is thrombocytopenia?
What is neutropenia?