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Glossary of Drug Theory

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Created by jbowde11

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What is a drug?
Substance which:

used in treatment
recognized in the US Pharmecopia
alters the nat. body function





2 Types of Pharmacology
Basic and Clinical

Basic is in vitro organ preparation, in animals, cell preparation.

Clincal is the study of drugs and how they affect humans.





7 drug categories
Drugs acting on...

nervous system
inflammation
kidney or heart
stomach or intestines
chemotherapeutic agents
blood
hormone antagonists









What is the first step in a chemical becoming a new drug?
Preclinical testing. 1-5 years
(In vitro, animal testing)
What is the 2nd step in a chemical becoming a new drug?
It becomes classified as an investigational new drug.
What is the 3rd step in a chemical becoming a new drug?
Clinical Testing 2-10 years

What are the 3 phases of clinical testing?
Phase I - Healthy Volunteers, safety, kinetics, metabolism

Phase II - Selected patients, dose-range, therapeutic efficacy

Phase III - Large numbers of selected patients, efficacy, safety



What is the 4th step in a chemical becoming a new drug?
NDA submitted and approved.
(12 months)
What is done after a new drug application is approved?
The drug is sold and given to patients for therapy, and are monitored for adverse reactions.
Year of the food and drug act
1906
Harrison Narcotic Act
1914 - opium and cocaine restrictions
Federal Food, Drug and Cosmetic Act
1938. Requires demonstration of drug safety.
Durham-Humphrey Amendments to FDA Act of 1951

Defines which drugs require a prescription

Kefauver-Harris Drug Amendments to FDC Act of 1962

Requires demonstration of drug efficacy

Controlled Substance Act of 1970

Created the scheduling system
Orphan Drug Act of 1983

The government encouraging pharmeceutical companies to develop drugs that only affect a small number of people.
7 years competition free.
Tax incentives.

Dietary Supplement Health and Education Act of 1994

regulates dietary supplements as foods, and not as drugs.
Controlled Substances Schedules

Schedule 1

High abuse potential, no accepted medical use. Examples: Heroin, Marijuana, LSD

Controlled Substances Schedules

Schedule 2

High abuse potential, accepted medical use, high incidence of physical dependence. Dispensing restrictions.

Examples: Morphine, amphetamine

Controlled Substances Schedules

Schedule 3

Lower abuse potential, accepted medical use, lower incidence of physical dependence. Dispensing restrictions.

Examples: Lortab, anabolic steroids

Controlled Substances Schedules

Schedule 4

Lower abuse potential than III, accepted medical use, limited physical dependence.

Examples: Valium,Ativan

Controlled Substances Schedules

Schedule 5

Low abuse potential, accepted medical use, limited physical dependence, may be prescription or OTC.

Examples: medications for the relief of coughs or diarrhea.

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