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Lehne's Pharmacology CH 3 questions with answers
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Lehne's Pharmacology CH 3 questions with answers
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Lehne's Pharmacology CH 3 questions withanswers
5 mImportant mtopics min mpharmacology: m- mANSWER: m m➡ m-drug mregulation
-new mdrug mdevelopment
-drug mnames
-OTC's
-sources mof mdrug minformation
-focused mon mproduct mlabeling mand mrequired mthat many mvariations mfrom mstandards mbe
mplaced mon mthe mlabel m- mANSWER: m m➡ mFederal mPure mFood mand mDrug mAct mof m1906
-addressed mdrug msafety
-created mafter mmore mthan m100 mpeople mdied mfrom musing ma mnew mmedication m- mANSWER: m
m➡ mFood, mDrug mand mCosmetic mAct mof m1938
-passed mby mCongress mafter mthalidomide mtragedy mof mbirth mdefects mand mfetal mdeath
-only mallowed mdrugs mthat mwere mproven mto mbe meffective minto mthe mmarket
-provided mrigorous mdrug mtesting m- mANSWER: m m➡ mHarris-Kefauver mAmendments mof m1962
-set mrules mfor mmanufacture mand mdistribution mof mdrugs mconsidered mto mhave mthe mpotential
mfor mabuse
-Schedules mI-V, mwhere mSchedule mI mwas mmost mdangerous mand mSchedule mV mwas msafest m-
mANSWER: m m➡ mControlled mSubstances mAct mof m1970
-passed mto maccelerate mFDA mreview mof mnew mdrugs
, -drug msponsors mpay mFDA mfees mto mfund mmore mdrug mreviewers;FDA mhas ma mstrict mtimetable
mto mcomplete mdrug mapplication m- mANSWER: m m➡ mPrescription mDrug mUser mFee mAct mPDUFA
mof m1992
-most mimportant mlegislation mon mdrug msafety msince mHarris-Kefauver mAmendments mof m1962
-rigorous moversight mof mdrug msafety mafter ma mdrug mhas mbeen mapproved
-has mlegal mauthority mto mrequire mpost-marketing msafety mstudies, mto morder mchanges min ma
mdrug's mlabel mto minclude mnew msafety minformation, mand mto mrestrict mdistribution mof ma mdrug
mbased mon msafety mconcerns m- mANSWER: m m➡ mFDA mAmendments mAct mFDAAA mof m2007
-allows mthe mFDA mto mregulate mcigarettes
-advertises mrestrictions mof mcigarettes
-prohibit mmarketing mto myouth
-require madvised mand mmore mprominent mwarning mlabels
-require mdisclosure mof mingredients min mtobacco mproducts mand mrestrict mharmful madditives
-monitor mnicotine myields mand mmandate mgradual mreduction mof mnicotine mto mnonaddictive
mlevels m- mANSWER: m m➡ mFamily mSmoking mPrevention mand mTobacco mControl mAct mof m2009
-most mreliable mway mto mobjectively massess mdrug mtherapies
-3 mfeatures minclude:use mof mcontrols, mrandomization, mand mblinding m- mANSWER: m m➡
mRandomized mcontrolled mtrials mRCT's
-preventing mbias min mdrug mstudies
-subjects mare meither mgiven mexperimental mdrug mor mplacebo
-determines mif mnew mtreatment mis mmore mor mless meffective mthan mstandard mtreatments m-
mANSWER: m m➡ muse mof mcontrols
-subjects mare mrandomly massigned mto meither mthe mcontrol mgroup mor mthe mexperimental mgroup
-prevents mbias m- mANSWER: m m➡ mrandomization
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