1 General Principles Of Pharm Flashcards
(47 cards)
4 areas of pharmacology
Pharmacotherapeutics
Pharmacokinetics
Pharmacodynamics
Toxicology
Define pharmacotherapeutics
the area of pharmacology that refers to the use of specific drugs to prevent, treat, or diagnose a disease.
Define pharmacokinetics
the study of how the body deals with the drugs in terms of the way it is absorbed, distributed, and eliminated.
Define pharmacodynamics
the analysis of what the drug does to the body, including the mechanism by which the drug exerts its effects.
Define toxicology
the study of the harmful effects of chemicals.
What are the 3 ways to identify a drug?
- Chemical name
- Generic name
- Trade name
What is the most effective way to refer to a drug?
Generic name/ official name
What is the difference between generic and brand name drugs?
They are bioequivalent, but there are different dosages of active ingredient.
BRAND IS STRONGER THAN GENERIC
What is the preclinical stage of creating a new drug?
Animal Studies using several different species.
1 - 2 yrs.
Obtained are: • Pharmacokinetics • Pharmacodynamics • Dosage • Toxicity
What’s an IND? Who determines what one is?
IND - Investigational New Drug
The FDA deems the drug safe for human trials
What is phase 1 of human trials?
- Purpose: obtain initial information about PHARMACOLOGIC action, and possible TOXIC effects in humans.
- Subjects: 20 to 80 HEALTHY volunteers.
- Time Period: < 1 yr
What is phase 2 of human clinical trials?
- Purpose: evaluate the EFFECTIVENESS of the drug, and assess side effects and other risks.
- Subjects: 200 to 300 subjects with a specific disease or pathologic condition.
- Time Period: 2 yrs.
What is phase 3 of a human clinical trial?
- Purpose: obtain additional information regarding the drug’s safety and effectiveness in a large patient population.
- Subjects: several hundred to several thousand patients with a specific disease or pathologic condition.
- Time Period: 3 yrs.
What is phase 4 of the drug approval process?
Postmarketing Surveillance
- Purpose: to continue to monitor drug’s safety and effectiveness for public use.
- Subjects: general patient populations.
- Time Period: Indefinite.
What makes an OTC drug safe?
- OTC are used to treat minor problems
- Judged to be safe for use without direct medical supervision if taken properly.
- Chances of toxic effects are usually small, when taken as recommended.
What is a schedule 1 drug?
- Highest potential for abuse.
- Not typically used as acceptable medical treatment in US.
- Restricted to approved research studies. ( marijuana as an antiemetic)
- Examples: heroin, LSD, mescaline, marijuana
What schedule is heroin?
Schedule 1
Which schedule is LSD?
Schedule 1
Which schedule is mescaline?
Schedule 1
Which schedule is marijuana?
Schedule 1
What are schedule 2 drugs?
- High potential for abuse.
- Approved for specific therapeutic purpose.
- Examples: morphine, fentanyl, methamphetamine
Which schedule is morphine?
Schedule 2
Which schedule is fentanyl?
Schedule 2
Which schedule is methamphetamine?
Schedule 2
