pharm

Question 1

pharmacodynamics

Answer 1

what the drug does to the body, the intensity of its effect and side effects

Question 2

pharmacokinetics

Answer 2

what the body does to the drug, rate and extent of absorption, rate of elimination

Question 3

Adverse Drug Events

Answer 3

includes adverse drug reactions as a subset, plus all other bad outcomes such as errors in prescribing, pharmacy, administration; greater than one day in hospital and cost of at least $9000; most occur on prescribing or at administration of meds

Question 4

Adverse drug reaction

Answer 4

a type of adverse drug event; may be based on specific drug action (predictable) or from action on off target receptors/atypical processing by body; drug-drug interactions, drug-food, hepatic, renal, idiosyncratic (individual differences) due to genetics or immunological (allergies)

Question 5

Pharmagenomics

Answer 5

the effects of an individual’s genetics on how they will respond to a drug

Question 6

IND

Answer 6

Investigational New Drug, permission to start human trials; after completion of pre-clinical testing, this is filed with the FDA to get permission to begin human testing

Question 7

NDA

Answer 7

New Drug Application, permission to market after passing clinical trials

Question 8

BLA

Answer 8

Biological License Application, permission to market biologicals after passing clinical trials

Question 9

NCE

Answer 9

new chemical entity, many fail during development or trial phases because they have unacceptable toxicity or they do not work in clinical trials

Question 10

NBE

Answer 10

new biological entity; subtype of NDA

Question 11

Proprietary drug

Answer 11

new drug that is protected by a patent to prevent anyone else from making/selling it; contrast with generics, which are cheaper forms of the drug which can be produced after patent expires (20 years)

Question 12

Polypharmacy

Answer 12

patients taking large number of medications; poses challenges in preventing drug-drug interactions; major problem for geriatric patients

Question 13

Requirements for drug to be approved by FDA

Answer 13

must be effective; may be toxic if benefits outweigh risks

Question 14

FDA approval process

Answer 14

in vitro studies, then animal studies- if success then submit IND; then clinical testing: Phase 1-3, if success- submit NDA; if approved, drug enters market and phase 4 (surveillance) starts; patent expires after 20 years and then generics become available

Question 15

Pre-clinical phase

Answer 15

cell, tissue, animal testing; used to figure out how a drug affects body systems; figure out drug’s mechanism of action; test using animal models for toxic effects- carcinogenic (can it cause cancer?) or can it cause fetal abnormalities

Question 16

Phase I clinical trials

Answer 16

carried out in small group, less than 100 healthy volunteers; Is this drug SAFE? Looks at pharmacokinetics- how the drug is absorbed, used, and excreted in the body

Question 17

Phase II

Answer 17

a few hundred patients who have the disorder the drug was intended for; does the drug work? Drug must be safe and EFFECTIVE to pass phase

Question 18

Phase III

Answer 18

larger more diverse group of patients; confirm efficacy of new drug compared to known drugs and track effects over time; safety, dosage, effectiveness

Question 19

what the FDA regulates

Answer 19

foods, human and vet drugs, biological products, medical devices, cosmetics, radiation producing products, advertising on Rx drugs; doesn’t regulate neutraceuticals/dietary supplements, water, OTC advertising, alcohol

Question 20

Phase IV

Answer 20

market experience; ensures that unexpected drug reactions are detected, reported, and evaluated; MedWatch, FDA Safety, Adverse Event Reporting

Question 21

Black Box Warning

Answer 21

reports the most serious or life threatening adverse events; FDA requires this to be on the box for a med that may cause significant risks, even if rare

Question 22

Orphan drug products

Answer 22

rare diseases affecting fewer than 200,000 people in the US; Orphan Drug Act passed to incentivize drug companies to make these drugs

Question 23

Right to Try laws

Answer 23

allow terminally ill patients to try meds that are not yet approved by the FDA as a last attempt

Question 24

-omab

Answer 24

mouse MAB, not commonly used in humans

Question 25

-ximab

Answer 25

chimeric (mouse/human) MAB

Question 26

-zumab

Answer 26

humanized MAB (has mouse CDR regions)

Question 27

-mumab

Answer 27

fully human antibody