What is a chemical name?
Assigned by the International Union of Pure and Applied Chemistry (IUPAC) and used only by chemists and researchers
Chemical names are often too complicated for everyday use.
What is a generic name?
Determined by the drug company along with the United States Adopted Names (USAN) council, used by healthcare providers
Generic names are simpler than chemical names.
What is a trade, brand, or proprietary name?
Created by the drug company upon FDA approval for marketing, becomes a trademark (™) or ®
This name is used for commercial purposes.
What role does the FDA play in drug testing?
Tests drugs to determine their effectiveness and safety
The FDA is responsible for ensuring that drugs are safe for public use.
What is in vitro testing?
Chemical analysis of a drug conducted in a laboratory using test tubes
This type of testing occurs before animal or human testing.
What does in vivo testing refer to?
Testing done on animals or humans
This testing helps determine side effects and toxic effects.
What is pharmacodynamics?
Describes the mechanism of action by which the drug produces its effects based on time and dose
It helps in understanding how drugs affect the body.
What is a frequency distribution curve?
A graph showing the number of animals who respond or do not respond to the drug and at what dose
Useful for understanding drug efficacy.
What is half-life?
The time required for the drug level in the blood to decrease from 100% to 50%
Shorter half-lives require more frequent dosing.
What is the therapeutic index (TI)?
The relative margin of safety between the dose that produces a therapeutic effect and the dose that produces a lethal effect
Higher TI indicates a safer drug.
What is an Investigational New Drug (IND) application?
A request submitted to the FDA by a drug company to test the drug in humans
This follows successful animal testing.
What occurs in Phase 1 of clinical drug trials?
10-100 healthy volunteers study safe dose range, evaluate side effects, and establish final correct dose
This phase takes 1-1.5 years.
What is studied during Phase 1 in addition to dosage?
Pharmacokinetics, which involves the movement of the drug through absorption, distribution, metabolism, and excretion
Understanding pharmacokinetics is crucial for determining drug behavior in the body.
What occurs in Phase 2 of clinical drug trials?
The drug is given to 50-500 patients who have the disease it will treat to determine its therapeutic effect
This phase usually takes about 2 years.
What characterizes Phase 3 of clinical trials?
The drug is given to thousands of ill patients in the exact manner it will be used once on the market
This phase lasts about 3 years.
What are double-blind studies?
Studies where neither the participants nor the researchers know who is receiving the drug or placebo
This method reduces bias in clinical trials.
How long does it typically take for a drug to go from creation to market?
On average, it takes 12 years
This includes all phases of testing and approval.
What are ancient sources in drug discovery?
Drugs derived from plant, animal, or mineral sources
Many modern drugs have origins in these sources.
What is an isomer in drug development?
A drug that has undergone molecular manipulation
Isomers can have different effects compared to their parent compounds.
What is recombinant DNA (rDNA)?
A method of creating new chemicals through genetic manipulation
This technique allows for the development of biologically active drugs.
Who regulates the marketing of Rx drugs?
The FDA, based on the Food, Drug, and Cosmetic Act
This ensures truthful advertising and safety information.
Who regulates the marketing of OTC drugs?
The Federal Trade Commission
They oversee advertising practices for non-prescription drugs.
How do drug companies traditionally advertise?
Through medical journals and doctor visits, using sales reps to provide drug samples
Direct-to-consumer marketing has become more common recently.
What is MedWatch?
The FDA’s safety information and adverse event reporting system on the Internet
Healthcare professionals and consumers can report adverse drug events here.
