Exam (elaborations)
NAPSR/CNPR EXAM
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Exam of 16 pages for the course NAPSRx CNPR at NAPSRx CNPR (NAPSR/CNPR EXAM)
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NAPSR/CNPR EXAMPharma6companies6must6submit6extensive6data6to6the6FDA6demonstrating6the6safety6an
d6effectiveness6of6new6drugs6before6receiving6approval6for6sale.6-6ans--True
Average6review6time6for6a6new6drug6-6ans--186months
Sales6Team6-6ans--Pg67
The6"engine6of6innovation,"6focused6on6discovering6or6inventing6promising6new6product.6
-6ans--Research6&6Development
This6includes6supply6chain,6manufacturing,6trade,6and6distribution6functions6of6the6busin
ess.6-6ans--Manufacturing6&6Operations
In62012,6FDA6regulators6approved6396new6drugs6for6use6in6the6U.S.6-6ans--True
3,0706new6meds6are6in6development6for6cancer.6-6ans--True
Define6Off-label6-6ans--
Usage6of6a6medication6for6purposes6other6than6the6specific6ones6appearing6on6the6label
Toxicity6-6ans--
The6extent,6quality,6or6degree6to6which6a6substance6is6poisonous6or6harmful6to6the6body
Institutional6review6Board6(IRB)6-6ans--
A6committee6of6physicians,6staticians,6community6advocated,6and6others6which6ensure6t
hat6a6clinical6trial6is6ethical6and6that6the6rights6of6the6study6participants6are6protected.6All6
clinical6trials6must6be6approved6by6an6IRB6before6they6begin.
Placebo6-6ans--Inactive6pill,6liquid,6or6powder6that6has6no6treatment6value6aka6sugar6pill
Edema6-6ans--Swelling
Asymptomatic6-6ans--Without6signs6or6symptoms
Clinical6Pharmacology6-6ans--
The6study6of6the6effects6and6movement6of6drugs6in6the6human6body
Anatomy6-6ans--The6study6of6basic6structures6of6the6body
Physiology6-6ans--The6study6of6how6those6body6structures6function
,Basic6clinical6pharmacology6involves636main6concepts6-6ans--
Pharmacodynamics,6Pharmacokinetics,6drug6distribution6and6elimination.
Pharmacodynamics6-6ans--
Study6of6the6biochemical6and6physiological6effects6of6drugs6and6their6mechanisms6of6acti
on6i.e.6the6study6of6what6a6drug6does6to6the6body.6It6describes6the6therapeutic6effects6of6
drugs6(pain6relief,6blood6pressure6reduction,6their6side6effects6and6their6sites6of6action.
Pharmacokinetics6-6ans--
Study6of6how6a6drug6is6processed6by6the6body,6with6emphasis6on6the6time6required6for6a
bsorption,6duration6of6action,6distribution,6and6method6of6excretion.6The6study6of6how6the
6body6affects6drugs.
Drug6distribution6&6elimination6-6ans--
Drug6delivery6systems,6route6of6administration6,6modes6of6excretion.
Plasma6-6ans--The6liquid6portion6of6the6blood6that6carries6proteins6and6other6substances
Organs6-6ans--
Specialized6cells6and6tissues6grouped6together6to6perform6specific6body6function6for6a6co
mmon6purpose.6(Kidney,6heart,6intestines,6and6skin)
Nucleus6-6ans--Brain6of6the6cell6that6regulates6all6activities.
Proteins6-6ans--A6nutrient6made6up6of6of6chains6of6amino6acids
Fats6-6ans--A6nutrient6stored6in6special6body6tissues6as6a6great6source6of6reserve6energy
Carbohydrates6-6ans--
A6nutrient6that6is6the6body's6immediate6source6of6energy.6It's6broken6down6to6glucose6an
d6used6for6immediate6metabolic6reactions.
Vitamins6-6ans--
A6nutrient6substance6necessary6for6growth,6development,6and6normal6regulation6of6meta
bolic6processes.6Must6be6taken6from6outside6the6body.
Minerals6-6ans--
A6nutrient6necessary6for6bodily6purposes6such6as6the6balance6of6body6fluid
Water6is6NOT6a6nutrient6-6ans--True
Body's6Major6Systems6-6ans--
Cardiovascular,6Respiratory,6nervous,6musculoskeletal,6reproductive,6immune
, Absorption6-6ans--
How6the6drug6passes6from6its6side6of6administration6into6the6bloodstream
Distribution6-6ans--
How6the6drug6is6dispersed6among6the6organs6after6absorption6into6the6blood
Metabolism6-6ans--How6the6active6part6of6a6drug6is6metabolized6into6a6more6water-
soluble6compound6that6can6be6readily6excreted6by6the6kidneys
Excretion6-6ans--
How6the6drug6is6eliminated6from6the6body.6Usually6drugs6are6eliminated6via6urine.6They6c
an6also6be6excreted6through6the6lungs,6skin,6or6breast6milk.
It6takes6about6106years6for6a6drug6to6hit6the6market6-6ans--True
Routes6of6drug6administration6-6ans--Pg626-29
Seven6rights6of6drug6administration6-6ans--pg630
Bioavailability6-6ans--
how6quickly6and6how6much6of6a6drug6reaches6its6intended6target6site6of6action
Bioequivalent6-6ans--
when6they6contain6the6same6active6ingredients6and6proceed6virtually6the6same6blood6lev
els6over6time.
Therapeutic6equivalence6-6ans--Production6of6the6same6medicinal6effect
Drug6elimination6and6Excretion6-6ans--pg634
Drug6Forms6-6ans--Pg635-38
Patent6last6206years6-6ans--True
Inactive6ingredients6-6ans--
Added6to6provide6bulk,6strength,6aid6dissolving,6color,6taste,6etc.6IAs6do6not6affect6the6bo
dy
Pharmaceutical6Ingredients6-6ans--Pg654
BID6-6ans--twice6a6day
Cmax6-6ans--Peak6plasma6concentration6on6a6measuring6curve
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