drugs

the science of chemicals that effect a living process

adverse effects of chemicals

" management" of disease with a medication

alters an effect already existing in a quantitative manner of changes

chemical name for a medication

a manufacture's name for the generic product

non-prescriptive agent

prescriptive agent

a non prescriptive drug that requires you to ask for it at the pharmacy, they keep track of how often someone gets that drug.

prescriptive agent that has the potential for abuse, all are prescriptive drugs.

generic medications that have been determined to be equivalent

are two medications given together that produce an effect equal to the sum of the effects of each agent

two medications given together that produce an effect much greater than the sum of the effects of each agent

is when two medications given together, but only one of the agents possess the required action, but that action is enhanced by the second agent.

is an agent that stimulates a receptor

is an agent that blocks a receptor from being stimulated

1938 food and drug cosmetic act - must prove safety (not effectiveness)

1962 kefaver-harris amendment - must prove efficacy / grandfather clause

• - chemical or substance not previously used in humans
• - new combination not used in combination before
• - new use for a previously issued drug
• - new dosage form

• phase 1 - determine safety and tolerated dose in a few "healthy" volunteers
• phase 2 - determine safety, efficacy and pharmacokinetics in selected "diseased" individuals
• phase 3 - determine safety and efficacy in widespread study
• phase 4 - drug marketed with surveillance

double blind - neither the patient nor the doctor know if the patient is taking the drug or a plecebo

single blind - doctor knows who is being tested or not, they can affect the outcome of the study.