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Pharmacokinetics and Pharmacodynamics
(Exam 1) Exam Questions And Answers|
Already Graded A+| Latest Update.
5 phases of drug development - Answer✔Drug discovery (5yrs), pre-clinical (1.5yrs), IND, clinical
(6yrs), NDA, FDA revision (2yrs), and mass production (2 yrs)
3 phases of clinical trials - Answer✔Phase 1- small population of healthy volunteers, phase 2-
those affected with the disease, phase 3- large population of placebo vs. drug
Prescription drug user fee app - Answer✔Fee passed in the 90's that paid for additional staff -->
eliminated the backlog of new drug applications
Phase 4 data - Answer✔information learned post approval which leads to off label use
How long do drug patents last? - Answer✔20 years
What leads to fast track drug development? - Answer✔Modifying an old drug or
cancer/infectious disease drugs
Primary literature - Answer✔original trials that can be found in journals --> free of bias
Secondary and tertiary literature - Answer✔review papers or summaries of original trials, apps,
textbooks --> can contain bias and/or misinformation
Key opinion leaders - Answer✔Lend credibility to claims of efficacy and safety of drugs.
Promote off label use to increase company profits
4 components of pharmacokinetics - Answer✔absorption, metabolism, distribution, excretion
What determines frequency of administration? - Answer✔half life
First pass effect/pre-systemic extraction - Answer✔How much of the drug gets metabolized or
extracted before it enters the systemic circulation
1
Pharmacokinetics and Pharmacodynamics
(Exam 1) Exam Questions And Answers|
Already Graded A+| Latest Update.
5 phases of drug development - Answer✔Drug discovery (5yrs), pre-clinical (1.5yrs), IND, clinical
(6yrs), NDA, FDA revision (2yrs), and mass production (2 yrs)
3 phases of clinical trials - Answer✔Phase 1- small population of healthy volunteers, phase 2-
those affected with the disease, phase 3- large population of placebo vs. drug
Prescription drug user fee app - Answer✔Fee passed in the 90's that paid for additional staff -->
eliminated the backlog of new drug applications
Phase 4 data - Answer✔information learned post approval which leads to off label use
How long do drug patents last? - Answer✔20 years
What leads to fast track drug development? - Answer✔Modifying an old drug or
cancer/infectious disease drugs
Primary literature - Answer✔original trials that can be found in journals --> free of bias
Secondary and tertiary literature - Answer✔review papers or summaries of original trials, apps,
textbooks --> can contain bias and/or misinformation
Key opinion leaders - Answer✔Lend credibility to claims of efficacy and safety of drugs.
Promote off label use to increase company profits
4 components of pharmacokinetics - Answer✔absorption, metabolism, distribution, excretion
What determines frequency of administration? - Answer✔half life
First pass effect/pre-systemic extraction - Answer✔How much of the drug gets metabolized or
extracted before it enters the systemic circulation
1
