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Pharmacokinetics and Pharmacodynamics (Exam 1) Questions And Correct Answers/ Latest Update / Already Graded

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5 phases of drug development Ans: Drug discovery (5yrs), pre-clinical (1.5yrs), IND, clinical (6yrs), NDA, FDA revision (2yrs), and mass production (2 yrs) 3 phases of clinical trials Ans: 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 Ans: Fee passed in the 90's that paid for additional staff -- eliminated the backlog of new drug applications 2 | P a g e Phase 4 data Ans: information learned post approval which leads to off label use How long do drug patents last? Ans: 20 years What leads to fast track drug development? Ans: Modifying an old drug or cancer/infectious disease drugs Primary literature Ans: original trials that can be found in journals -- free of bias Secondary and tertiary literature Ans: review papers or summaries of original trials, apps, textbooks -- can contain

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Pharmacokinetics and Pharmacodynamics
(Exam 1) Questions And Correct Answers/
Latest Update / Already Graded
5 phases of drug development


Ans: Drug discovery (5yrs), pre-clinical (1.5yrs), IND, clinical (6yrs),

NDA, FDA revision (2yrs), and mass production (2 yrs)




3 phases of clinical trials


Ans: 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


Ans: Fee passed in the 90's that paid for additional staff -->

eliminated the backlog of new drug applications

, 2 | Page

Phase 4 data


Ans: information learned post approval which leads to off label use




How long do drug patents last?


Ans: 20 years




What leads to fast track drug development?


Ans: Modifying an old drug or cancer/infectious disease drugs




Primary literature


Ans: original trials that can be found in journals --> free of bias




Secondary and tertiary literature


Ans: review papers or summaries of original trials, apps, textbooks --

> can contain bias and/or misinformation

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