CPPS 304 EVALUATION EXAM 2026 QUESTIONS AND
SOLUTIONS RATED A+
✔✔Technology that facilitates compound-centred approach (2) - ✔✔combinatorial
chemistry
high throughput screening
✔✔Combinatorial chemistry - ✔✔once a single compound has been discovered, make
different changes/variations off it
allows for the generation of a large number of compounds from a small number of
precursors
✔✔High throughput screening - ✔✔automated system that allows for the screening of
thousands of compounds
screens for: receptor binding, biochemical/cellular targets
✔✔Target entered approach to drug discovery - ✔✔common in 21 century
identify/characterize the target first, then design a drug to hit the target
- "rational drug design"
✔✔What facilitates target-centred approach (2) - ✔✔- ability to characterize receptors
through techniques like protein crystallography
- better understanding of the mechanisms of diseases
✔✔Example of target-centred therapy: immunotherapy - ✔✔pembrolizumab - targets
programmed cell death proteins (PD)-1
T cells remain active to attack tumour cells
✔✔When to patent - ✔✔once a molecule is deemed sufficiently promising
✔✔What does patenting do? - ✔✔grants exclusivity to the holder of the patent for
marketing of the product
protects the intellectual property behind the product
✔✔How long does a patent last in Canada - ✔✔20 years
+8 for the years it takes to actually get a product to market
✔✔What can happen after a patent expires? - ✔✔another company may 'copy' the drug
and sell it themselves
- where generic versions come in
✔✔How can patents be challenged in Canada - ✔✔if a generic manufacturer can prove
that the patent holder is not marketing their product, they can infringe upon it
, ✔✔Why do some people think patent times should be shorter - ✔✔- would increase
access to the product
- lowers costs (generics are usually cheaper)
✔✔Why do some people think patent times should be longer - ✔✔- rewards innovation
- encourages research (will make more money off the product)
✔✔Stages of drug approval (2) - ✔✔1. pre-clinical - performed on animals
2. clinical
✔✔What are the key elements of preclinical testing? (4) - ✔✔pharmacodynamics
(selectivity?)
pharmacokinetics (t1/2, routes of elimination)
toxicity (therapeutic index)
pharmaceutical development (what dosage forms are preferred)
✔✔Drug approval agencies - ✔✔canada - health canada
usa - food and drug administration (FDA) - considered to by the most thorough
(expertise)
europe - European medicines agency (EMA)
✔✔How many passes of clinical testing - ✔✔4 - done on humans
✔✔drug approval process in regards to different jurisdictions - ✔✔manufacture need to
choose where to submit and when
- can have multiple reviews run simultaneously
✔✔Branch of health canada responsible for Rx drugs - ✔✔therapeutic products
directorate (TPD)
- split into 15 offices
✔✔Regulatory body's involvement with clinical trials - ✔✔- may conduct inspections of
clinical sites
- ensures the proper protocols are being followed (id not, sites may have their data
excluded)
✔✔Pase 1 type/size - ✔✔small
open label or uncontrolled (no control group)
often healthy volunteers
✔✔Phase 1 focus/goals - ✔✔- get baseline levels (in healthy people)
- pharmacokinetics - how is drug metabolized?
- dosing - range?
- safety
SOLUTIONS RATED A+
✔✔Technology that facilitates compound-centred approach (2) - ✔✔combinatorial
chemistry
high throughput screening
✔✔Combinatorial chemistry - ✔✔once a single compound has been discovered, make
different changes/variations off it
allows for the generation of a large number of compounds from a small number of
precursors
✔✔High throughput screening - ✔✔automated system that allows for the screening of
thousands of compounds
screens for: receptor binding, biochemical/cellular targets
✔✔Target entered approach to drug discovery - ✔✔common in 21 century
identify/characterize the target first, then design a drug to hit the target
- "rational drug design"
✔✔What facilitates target-centred approach (2) - ✔✔- ability to characterize receptors
through techniques like protein crystallography
- better understanding of the mechanisms of diseases
✔✔Example of target-centred therapy: immunotherapy - ✔✔pembrolizumab - targets
programmed cell death proteins (PD)-1
T cells remain active to attack tumour cells
✔✔When to patent - ✔✔once a molecule is deemed sufficiently promising
✔✔What does patenting do? - ✔✔grants exclusivity to the holder of the patent for
marketing of the product
protects the intellectual property behind the product
✔✔How long does a patent last in Canada - ✔✔20 years
+8 for the years it takes to actually get a product to market
✔✔What can happen after a patent expires? - ✔✔another company may 'copy' the drug
and sell it themselves
- where generic versions come in
✔✔How can patents be challenged in Canada - ✔✔if a generic manufacturer can prove
that the patent holder is not marketing their product, they can infringe upon it
, ✔✔Why do some people think patent times should be shorter - ✔✔- would increase
access to the product
- lowers costs (generics are usually cheaper)
✔✔Why do some people think patent times should be longer - ✔✔- rewards innovation
- encourages research (will make more money off the product)
✔✔Stages of drug approval (2) - ✔✔1. pre-clinical - performed on animals
2. clinical
✔✔What are the key elements of preclinical testing? (4) - ✔✔pharmacodynamics
(selectivity?)
pharmacokinetics (t1/2, routes of elimination)
toxicity (therapeutic index)
pharmaceutical development (what dosage forms are preferred)
✔✔Drug approval agencies - ✔✔canada - health canada
usa - food and drug administration (FDA) - considered to by the most thorough
(expertise)
europe - European medicines agency (EMA)
✔✔How many passes of clinical testing - ✔✔4 - done on humans
✔✔drug approval process in regards to different jurisdictions - ✔✔manufacture need to
choose where to submit and when
- can have multiple reviews run simultaneously
✔✔Branch of health canada responsible for Rx drugs - ✔✔therapeutic products
directorate (TPD)
- split into 15 offices
✔✔Regulatory body's involvement with clinical trials - ✔✔- may conduct inspections of
clinical sites
- ensures the proper protocols are being followed (id not, sites may have their data
excluded)
✔✔Pase 1 type/size - ✔✔small
open label or uncontrolled (no control group)
often healthy volunteers
✔✔Phase 1 focus/goals - ✔✔- get baseline levels (in healthy people)
- pharmacokinetics - how is drug metabolized?
- dosing - range?
- safety
