Summary of the entire course Preclinical Drug Research (18/20): This is a compact summary of the whole course from the subject Preclinical Drug Research (slides, lectures, and all the important information from the insert) & elaboration of all the old exam questions from the course Preclinical Drug...
Prof. Maes Exam consists of analyzing an insert, oral part and a written part. Especially testing the
various toxicity (reproduction, general, core battery, genotoxicity) are important, as well as
pharmacokinetics and the various CYP450 enzyme testing. He is very friendly during the exam and
makes you really feel at ease if he isn’t short in time, and if that’s the case, please ask him to let you
speak because he tends to say some things before you even can, unfortunately, especially if he’s
short in time. You get 8 oral questions about the insert, which are sometimes not really about the
insert itself, be aware of that! But if you learn the whole course this shouldn’t be a problem.
Exam questions:
Main question: insert as practiced in class! This is for him the most important part of the exam!
Furthermore, 3 short written questions, which he rarely proposes an additional question at.
Examples:
1. Briefly discuss the in vitro cellular-based assays and give them benefits.
2. Discuss the topological toxicity tests.
3. Why are the pharmaceutical companies having increasing difficulties to bring new drugs to the
market?
1. What is a whole-body autoradiography and what is it used?
2. Discuss the development costs and revenue cycle, give some major franchises and orphan vs.
neglected
3. Importance of patent for drug discovery and development
1. Transgenic animal testing
2. Biopharmaceuticals and the difference with conventional products
3. Leaflet Zantac (was important to realize that the AUC was not really important because it typically
works in the stomach so uptake in blood is not necessary / required)
1. What are the most common GM interactions and how they are tested
2. Discuss hERG-test and when this test is carried out
3. Difference between pharmaceuticals and biopharmaceuticals + why make a difference in drug
development
1. Dermal Toxicity
2. Factors which influence the oral bioavailability
3. Whole body auto radiography
1. What horsepower and toxicity tests do you need to get to Phase 1 clinical trials are
2. Development and revenue cycle and orphan and neglected diseases
3. What in vitro tests for membrane permeability
1. Techniques for selective expression target
, 2. Why ADME is different in children as in adults
3. Advantages and disadvantages of small drugs vs. Biopharmaceutical
Exam questions 2017
Group ?
- Ames
- Core battery
- Paediatrics vs adult
- Biopharmaceuticals: advantages & disadvantages
- Insert: Zantac
Group 8:
- Biotransformation is important for the elimination of a drug. Explain briefly phase I and
phase II. How are they studied?
- Why are there only a few useable targets found with the help of genomics and proteomics?
- Explain briefly these pharmacokinetic concepts: clearance, steady-state, one-compartment
model, two-compartment model, zero-order elimination, first-order elimination.
- Why is a patent so important in drug-discovery? Which patents exist?
- Insert: Sporanox (itraconazole)
Group 2:
- Alternative tests for Ames test
- Something about a graph of revenues
- Insert: methadon
Exam January 2019
Group 1
1. Why are there only a few useable targets found with the help of genomics and proteomics?
Explain: “genome” “transcriptome” “metabolome” “proteome”. Which specific assay is used
to study the transcriptome ?
2. What is whole body autoradiography and what is it used ? What is the difference with mass
balance study ?
3. Isolated organs are frequently used in in vitro studies. Give some advantages and limitations.
Insert: Lopressor
Group 3
1. Give a schematic overview of the homogeneous vs heterogeneous assays
2. What is the hERG test? Where would you place this in the drug development flow-chart?
What other tests can you perform? (with the last question I think he meant the risk
identification battery)
3. List the cascade of assays for dermal (topical) toxicity
Insert: Methadone
Group ?
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