Download Final Exam Key spring 2010

Chemistry 255 Final Exam Key
Please put your name on this exam. Be sure to answer all of the questions as
completely as possible. I hope you’ve learned a lot and gotten what you needed out
of this class. Please keep in touch.
100 points
(20) 1. Define the following terms:
a. FDA Food and Drug Administration
b. IND Investigational New Drug; permission to give an unapproved drug to
humans for clinical trials
c. NDA New Drug Application: Permission to get drug approved and sell it
d. GLP good laboratory practices: a set of regulations governing testing of drugs
in animals.
e. GCP good clinical practice: : a set of regulations governing testing of drugs in
humans
f. lead compound a compound showing some promise in a biological screen
g. biologic a protein or product from blood or tissue
h. MSDS Material Safety Data Sheet
i. clinical trial a test of a drug in humans
j. chemical process development determination of the best synthetic route for
manufacturing a drug.
(5) 2. Before a drug is approved, how many potential drugs were tried?
about 1 million
Chemistry 255 Final Exam Key Pg. 2
(5) 3. Approximately how long does it take for the drug discovery and development
process? What does it cost?
about 10 years and about $ 1 billion
(5) 4. For a drug to approved, it must be __safe_________ and _effective___.
(5) 5. What is ADME?
Absorption, Distribution, Metabolism and Excretion. It is the pharmacology of what
happens to a drug from when it enters the body until it leaves
(10) 6. Give the stages of drug discovery and development. Give a brief description of
each.
Discovery: synthesis of a large number of molecules and testing in a screen such as a
receptor binding assay.
Lead optimization: tweaking of positive in the screen to improve performance in the
screen
animal testing: dosing in animals to determine toxicity and ADME
clinical trials: testing in humans for safety and efficacy
process development: starts once a lead is determined and continues during process until
approval
Chemistry 255 Final Exam Key Pg. 3
(5) 7. What is the goal of animal testing?
determination of toxicity and ADME
(10) 8. Describe the four phases of clinical trials.
Phase I: about 101 healthy volunteers are given drug to get ADME in humans and side
effects and dose ranging:
Phase II: about 102 "healthy sick people" they have the disorder, but are otherwise
healthy. First look at efficacy
Phase III: pivotal …103 - 104 people. less controlled. can have other problems. looking
for more data in a broader range
Phase IV: after market surveillance…millions
(5) 8. In my life, I’ve heard many people ask suggest that drugs be tested on prisoners.
Why is this a bad idea?
Main problem is lack of informed consent. For prisoners it would be more like coerced
consent. In addition, prisoners are not a broad heterogeneous population so the data
would not be very indicative.
(5) 9. What is the most expensive part of drug discovery and development? Why?
clinical trials: two reasons: 1. the involvement of health care professionals that have
high salaries and 2: the scope of the trials….thousands of subjects and several years
Chemistry 255 Final Exam Key Pg. 4
(5) 10. The synthetic pathway to a manufactured drug is never the same pathway by
which it was originally made. Give 3 reasons why this is.
most have to do with scaleup and yield. Need high purity and high percent yield. In
addition when we scaleup….like a billion fold (from milligrams to tons) issues such as
heat, mixing, toxic chemical usage, etc. become much larger. So the types of chemical
reactions we can do have to limit those problems.
(5) 11a. What is “validation”?
proving that an analytical method works
b. Complete the following:
If it isn't written down, ___it didn't happen__________________
(5) 12. For patents, answer the following questions:
a. How long does a patent last?
20 years
b.What does a patent prevent?
others from selling the patented item
c. Why are patents beneficial to society, not just inventors?
2 things: exclusivity and profit motive drive innovation. In addition, to get a
patent, you have to tell how something is made so it disseminates information
(5) 13. What is informed consent? Why is it important?
a document that ensures that the subject of a clinical trial is well-informed as to what they
will be subjected to and that they understand all of the risks. And that they consent to the
being a subject.
Important to protect test subjects
(5) 14. For this question, there is no right or wrong answer, just support what you say.
Are those in the pharmaceutical industry the good guys, or the bad guys?