Lehne's Pharmacology CH 3 Test
Questions And Accurate Answers.
-drug regulation
-new drug development
-drug names
-OTC's
-sources of drug information - Answer 5 Important topics in pharmacology:
Federal Pure Food and Drug Act of 1906 - Answer -focused on product labeling and required that any
variations from standards be placed on the label
Food, Drug and Cosmetic Act of 1938 - Answer -addressed drug safety
-created after more than 100 people died from using a new medication
Harris-Kefauver Amendments of 1962 - Answer -passed by Congress after thalidomide tragedy of birth
defects and fetal death
-only allowed drugs that were proven to be effective into the market
-provided rigorous drug testing
Controlled Substances Act of 1970 - Answer -set rules for manufacture and distribution of drugs
considered to have the potential for abuse
-Schedules I-V, where Schedule I was most dangerous and Schedule V was safest
Prescription Drug User Fee Act PDUFA of 1992 - Answer -passed to accelerate FDA review of new drugs
-drug sponsors pay FDA fees to fund more drug reviewers;FDA has a strict timetable to complete drug
application
FDA Amendments Act FDAAA of 2007 - Answer -most important legislation on drug safety since Harris-
Kefauver Amendments of 1962
, -rigorous oversight of drug safety after a drug has been approved
-has legal authority to require post-marketing safety studies, to order changes in a drug's label to include
new safety information, and to restrict distribution of a drug based on safety concerns
Family Smoking Prevention and Tobacco Control Act of 2009 - Answer -allows the FDA to regulate
cigarettes
-advertises restrictions of cigarettes
-prohibit marketing to youth
-require advised and more prominent warning labels
-require disclosure of ingredients in tobacco products and restrict harmful additives
-monitor nicotine yields and mandate gradual reduction of nicotine to nonaddictive levels
Randomized controlled trials RCT's - Answer -most reliable way to objectively assess drug therapies
-3 features include:use of controls, randomization, and blinding
use of controls - Answer -preventing bias in drug studies
-subjects are either given experimental drug or placebo
-determines if new treatment is more or less effective than standard treatments
randomization - Answer -subjects are randomly assigned to either the control group or the
experimental group
-prevents bias
single blinding - Answer -subjects involved in study do not know to which study group individual
subjects have been assigned to
double blinding - Answer neither researchers or subjects know who's in which study group
preclinical testing - Answer drugs are evaluated for toxicities, pharmacokinetic properties, and
potentially useful biologic effects
Questions And Accurate Answers.
-drug regulation
-new drug development
-drug names
-OTC's
-sources of drug information - Answer 5 Important topics in pharmacology:
Federal Pure Food and Drug Act of 1906 - Answer -focused on product labeling and required that any
variations from standards be placed on the label
Food, Drug and Cosmetic Act of 1938 - Answer -addressed drug safety
-created after more than 100 people died from using a new medication
Harris-Kefauver Amendments of 1962 - Answer -passed by Congress after thalidomide tragedy of birth
defects and fetal death
-only allowed drugs that were proven to be effective into the market
-provided rigorous drug testing
Controlled Substances Act of 1970 - Answer -set rules for manufacture and distribution of drugs
considered to have the potential for abuse
-Schedules I-V, where Schedule I was most dangerous and Schedule V was safest
Prescription Drug User Fee Act PDUFA of 1992 - Answer -passed to accelerate FDA review of new drugs
-drug sponsors pay FDA fees to fund more drug reviewers;FDA has a strict timetable to complete drug
application
FDA Amendments Act FDAAA of 2007 - Answer -most important legislation on drug safety since Harris-
Kefauver Amendments of 1962
, -rigorous oversight of drug safety after a drug has been approved
-has legal authority to require post-marketing safety studies, to order changes in a drug's label to include
new safety information, and to restrict distribution of a drug based on safety concerns
Family Smoking Prevention and Tobacco Control Act of 2009 - Answer -allows the FDA to regulate
cigarettes
-advertises restrictions of cigarettes
-prohibit marketing to youth
-require advised and more prominent warning labels
-require disclosure of ingredients in tobacco products and restrict harmful additives
-monitor nicotine yields and mandate gradual reduction of nicotine to nonaddictive levels
Randomized controlled trials RCT's - Answer -most reliable way to objectively assess drug therapies
-3 features include:use of controls, randomization, and blinding
use of controls - Answer -preventing bias in drug studies
-subjects are either given experimental drug or placebo
-determines if new treatment is more or less effective than standard treatments
randomization - Answer -subjects are randomly assigned to either the control group or the
experimental group
-prevents bias
single blinding - Answer -subjects involved in study do not know to which study group individual
subjects have been assigned to
double blinding - Answer neither researchers or subjects know who's in which study group
preclinical testing - Answer drugs are evaluated for toxicities, pharmacokinetic properties, and
potentially useful biologic effects
