pharm ch. 2 drug leg

Gives the drug its chemical and biologic properties

Drug nomenclature

INDA

What does the FDA do?

4 phases of human studies

Involves explanation of purpose of study
explains procedures
explains risks

Small number of healthy volunteers
determines opitmal dosage, pharmocokinetics, several tests-blood samples
lasts 5-7 years

Small # of volunteers with disease or condition Determines the drugs effectiveness and side effects
lasts 5-7 years

large number of patients with disease or condition at a medical research center
Determine infrequent rare side effects
look for risks of drug
dosage, range, saftey, effectiveness

Used to compare new drug with already existing medication in that class
post marketing study to evaluate the saftey effects of currently used drugs

NDA

NDC

how long does a new drug have a patent?

What two criteria in order to be generically equivalent?

Drug that has identical amounts of the same active chemical ingredients in the same dosage form that has the same STRENGTH, QUALITY, and PURITY

When a drug administered in the same amount provides the same theraputic effect-inluding duration and intensity

Drug organization into two groups

Cateogorized by theraputic usefulness

characterized by how the drug works

Used to compare and evaluate drug response among diff drugs that are similar

used to determine frequency of administration of medication in order to maintain an effective drug response

*The first US law passed to protect the public from adulterated or mislabeled drugs
required that drugs meet standards of strength and purity
required that the type and amount of narcotic be listed on the label

Prohibited the use fo fraudulent therapeutic clamims by drug companies

Aimed at curing drug addiction or dependence
established the word "narcotic"
proved that narcotic drugs produced physical or psychological dependence

*designated the United states pharmacopeia (USP) and the National formulary as official standards and empowered the federal governament to enforce them

stated that drug products that entered the market needed to be properly tested for safety
required that drug lables and literature by complete and accurate, stating the dose, manufacturer's name and address, lists and amounts of potentialy harmful ingredients, a warning if the drug might be habit-forming, directions for use, and contraindications

designed the "birth of the legend"
stated that prescriptions for narcotics, hypnotics, habit-forming drugs, and harmful drugs could be refilled only iwht a new prescription, and required tah tthe label state this fact. Specified how prescription drugs and refills could be ordered and dispensed.

required that drug products must be effective before entering the market.

designed to improve the administration adn regulation of the manufacturing, distribution,a dn dispensing of controlled substances by legitimate handlers of these drugs to help reduce their widespread dispersioninto illicit markets.
this act grouped controlled substances into five categories based on a drug's potential for abuse and medical effectiveness
It limited the number of perscription refills for controlled substances (5)

This administration was created to watch over the controlled Substance Act of 1970

Provided grants to research compainies to develop new drugs for diseases or conditions that were rare

Controlled Substances are divided into what categories

Drugs in Schedule I

Drugs in schedule II

Schedule III drugs

Schedule IV drugs

Schedule V drugs

a number given to a physican or place that has narcotics

Drugs are divided into 2 categories

Legend Drugs

What catedgory are legend drugs and Controlled substances (schedule I-V)

how can you get a prescription

What is a precription