Questions and Answers A+ Graded
Pharma .companies .must .submit .extensive .data .to .the .FDA .demonstrating .the
.safety .and .effectiveness .of .new .drugs .before .receiving .approval .for .sale. .-
.CORRECT .ANSWER-True
Average .review .time .for .a .new .drug .- .CORRECT .ANSWER-18 .months
Sales .Team .- .CORRECT .ANSWER-Pg .7
The ."engine .of .innovation," .focused .on .discovering .or .inventing .promising .new
.product. .- .CORRECT .ANSWER-Research .& .Development
This .includes .supply .chain, .manufacturing, .trade, .and .distribution .functions .of
.the .business. .- .CORRECT .ANSWER-Manufacturing .& .Operations
In .2012, .FDA .regulators .approved .39 .new .drugs .for .use .in .the .U.S. .- .CORRECT
.ANSWER-True
3,070 .new .meds .are .in .development .for .cancer. .- .CORRECT .ANSWER-True
Define .Off-label .- .CORRECT .ANSWER-Usage .of .a .medication .for .purposes .other
.than .the .specific .ones .appearing .on .the .label
Toxicity .- .CORRECT .ANSWER-The .extent, .quality, .or .degree .to .which .a
.substance .is .poisonous .or .harmful .to .the .body
Institutional .review .Board .(IRB) .- .CORRECT .ANSWER-A .committee .of
.physicians, .staticians, .community .advocated, .and .others .which .ensure .that .a
.clinical .trial .is .ethical .and .that .the .rights .of .the .study .participants .are
.protected. .All .clinical .trials .must .be .approved .by .an .IRB .before .they .begin.
Placebo .- .CORRECT .ANSWER-Inactive .pill, .liquid, .or .powder .that .has .no
.treatment .value .aka .sugar .pill
Edema .- .CORRECT .ANSWER-Swelling
Asymptomatic .- .CORRECT .ANSWER-Without .signs .or .symptoms
,Clinical .Pharmacology .- .CORRECT .ANSWER-The .study .of .the .effects .and
.movement .of .drugs .in .the .human .body
Anatomy .- .CORRECT .ANSWER-The .study .of .basic .structures .of .the .body
Physiology .- .CORRECT .ANSWER-The .study .of .how .those .body .structures
.function
Basic .clinical .pharmacology .involves .3 .main .concepts .- .CORRECT .ANSWER-
Pharmacodynamics, .Pharmacokinetics, .drug .distribution .and .elimination.
Pharmacodynamics .- .CORRECT .ANSWER-Study .of .the .biochemical .and
.physiological .effects .of .drugs .and .their .mechanisms .of .action .i.e. .the .study .of
.what .a .drug .does .to .the .body. .It .describes .the .therapeutic .effects .of .drugs
.(pain .relief, .blood .pressure .reduction, .their .side .effects .and .their .sites .of
.action.
Pharmacokinetics .- .CORRECT .ANSWER-Study .of .how .a .drug .is .processed .by
.the .body, .with .emphasis .on .the .time .required .for .absorption, .duration .of
.action, .distribution, .and .method .of .excretion. .The .study .of .how .the .body
.affects .drugs.
Drug .distribution .& .elimination .- .CORRECT .ANSWER-Drug .delivery .systems,
.route .of .administration ., .modes .of .excretion.
Plasma .- .CORRECT .ANSWER-The .liquid .portion .of .the .blood .that .carries
.proteins .and .other .substances
Organs .- .CORRECT .ANSWER-Specialized .cells .and .tissues .grouped .together .to
.perform .specific .body .function .for .a .common .purpose. .(Kidney, .heart,
.intestines, .and .skin)
Nucleus .- .CORRECT .ANSWER-Brain .of .the .cell .that .regulates .all .activities.
Proteins .- .CORRECT .ANSWER-A .nutrient .made .up .of .of .chains .of .amino .acids
Fats .- .CORRECT .ANSWER-A .nutrient .stored .in .special .body .tissues .as .a .great
.source .of .reserve .energy
Carbohydrates .- .CORRECT .ANSWER-A .nutrient .that .is .the .body's .immediate
.source .of .energy. .It's .broken .down .to .glucose .and .used .for .immediate
.metabolic .reactions.
Vitamins .- .CORRECT .ANSWER-A .nutrient .substance .necessary .for .growth,
.development, .and .normal .regulation .of .metabolic .processes. .Must .be .taken
.from .outside .the .body.
Minerals .- .CORRECT .ANSWER-A .nutrient .necessary .for .bodily .purposes .such
.as .the .balance .of .body .fluid
, Water .is .NOT .a .nutrient .- .CORRECT .ANSWER-True
Body's .Major .Systems .- .CORRECT .ANSWER-Cardiovascular, .Respiratory,
.nervous, .musculoskeletal, .reproductive, .immune
Absorption .- .CORRECT .ANSWER-How .the .drug .passes .from .its .side .of
.administration .into .the .bloodstream
Distribution .- .CORRECT .ANSWER-How .the .drug .is .dispersed .among .the .organs
.after .absorption .into .the .blood
Metabolism .- .CORRECT .ANSWER-How .the .active .part .of .a .drug .is .metabolized
.into .a .more .water-soluble .compound .that .can .be .readily .excreted .by .the
.kidneys
Excretion .- .CORRECT .ANSWER-How .the .drug .is .eliminated .from .the .body.
.Usually .drugs .are .eliminated .via .urine. .They .can .also .be .excreted .through .the
.lungs, .skin, .or .breast .milk.
It .takes .about .10 .years .for .a .drug .to .hit .the .market .- .CORRECT .ANSWER-True
Routes .of .drug .administration .- .CORRECT .ANSWER-Pg .26-29
Seven .rights .of .drug .administration .- .CORRECT .ANSWER-pg .30
Bioavailability .- .CORRECT .ANSWER-how .quickly .and .how .much .of .a .drug
.reaches .its .intended .target .site .of .action
Bioequivalent .- .CORRECT .ANSWER-when .they .contain .the .same .active
.ingredients .and .proceed .virtually .the .same .blood .levels .over .time.
Therapeutic .equivalence .- .CORRECT .ANSWER-Production .of .the .same
.medicinal .effect
Drug .elimination .and .Excretion .- .CORRECT .ANSWER-pg .34
Drug .Forms .- .CORRECT .ANSWER-Pg .35-38
Patent .last .20 .years .- .CORRECT .ANSWER-True
Inactive .ingredients .- .CORRECT .ANSWER-Added .to .provide .bulk, .strength, .aid
.dissolving, .color, .taste, .etc. .IAs .do .not .affect .the .body
Pharmaceutical .Ingredients .- .CORRECT .ANSWER-Pg .54
BID .- .CORRECT .ANSWER-twice .a .day
Cmax .- .CORRECT .ANSWER-Peak .plasma .concentration .on .a .measuring .curve