Complete the Restorital - How Do We Establish Safety Case Study
1. What does this case study illustrate about the limitations of safety testing of drugs in
animal studies?
Before a new drug could be used in the market, it has to be approved by FDA and the new drugs
called Restorial was approved by FDA. This drug is meant to prevent fractures caused by
osteoporosis that did not respond well to other medications. it was tested on animals and did not
show any evidence of carcinogenic or fertility problems on dosage is beyond the normal ranges
for patients. when being tested on animals, it does not always detect subsequent effect in human
and later found That beyond the normal range it could cause life threatening liver damage
2. What does this case study illustrate about the limitations of phase one and phase two
drug testing?
On phase one, duration of the exposure to the drug is too short compared to real life and
drug testing can be done on a smaller number of participant and the effect can only be expected
to be sensitive to organs such as liver, kidney, testicles. Phase two trial are small and
uncontrolled sometimes and the trial are designed to determine effectiveness
3. What does this case study illustrate about the limitations of safety testing of drugs using
randomized controlled trials?
randomized control trials are not effective if they're not planned, conducted, analyzed ad
reported properly. in this case there were two randomized control trials performed, and 1000
patient demonstrated the drug was able to modestly increase bone density for post-menopausal
women with osteoporosis who did not have luck with other medications
4. What does this case study illustrate about the potential dangers of using approved drugs?
It may be advertised and marketed for a particular indication, the one for which it was research
and approved, but it may not work for every patient who has complicated health condition. other
medication that the patients take can interact with other medication which could lead life-
threatening conditions
5. How could the FDA use its new authority provided in the 2007 amendments to prevent this type
of problem from occurring?
There are requirements in place to have more representative patient to be included in
randomized control trials and follow-up studies of drugs to monitor their performances in clinical
practice. also, by implementing large database system to link pharmacy record with electronic
medication worker to evaluate side effect continuously
1. What does this case study illustrate about the limitations of safety testing of drugs in
animal studies?
Before a new drug could be used in the market, it has to be approved by FDA and the new drugs
called Restorial was approved by FDA. This drug is meant to prevent fractures caused by
osteoporosis that did not respond well to other medications. it was tested on animals and did not
show any evidence of carcinogenic or fertility problems on dosage is beyond the normal ranges
for patients. when being tested on animals, it does not always detect subsequent effect in human
and later found That beyond the normal range it could cause life threatening liver damage
2. What does this case study illustrate about the limitations of phase one and phase two
drug testing?
On phase one, duration of the exposure to the drug is too short compared to real life and
drug testing can be done on a smaller number of participant and the effect can only be expected
to be sensitive to organs such as liver, kidney, testicles. Phase two trial are small and
uncontrolled sometimes and the trial are designed to determine effectiveness
3. What does this case study illustrate about the limitations of safety testing of drugs using
randomized controlled trials?
randomized control trials are not effective if they're not planned, conducted, analyzed ad
reported properly. in this case there were two randomized control trials performed, and 1000
patient demonstrated the drug was able to modestly increase bone density for post-menopausal
women with osteoporosis who did not have luck with other medications
4. What does this case study illustrate about the potential dangers of using approved drugs?
It may be advertised and marketed for a particular indication, the one for which it was research
and approved, but it may not work for every patient who has complicated health condition. other
medication that the patients take can interact with other medication which could lead life-
threatening conditions
5. How could the FDA use its new authority provided in the 2007 amendments to prevent this type
of problem from occurring?
There are requirements in place to have more representative patient to be included in
randomized control trials and follow-up studies of drugs to monitor their performances in clinical
practice. also, by implementing large database system to link pharmacy record with electronic
medication worker to evaluate side effect continuously
