midterm 2 fuck Flashcards
drug discovery is gay
who sponsors clinical trials and where does it happen
sponsored by company making drug. happens at universities, private research organizations, hospitals
who is the principal investigator
medical doctor with expertise in area
what does trial entry criteria include
eligibility and inclusion
how are phase 1 trial dosages determinned and what are the two ways dosages are tested
dosing guided by preclinical, multiplied by a factor to be conservative. you have single ascending (increasing amount) and multiple ascending (tests accumulation, one dosage level over many days)
what does phase 1 trials try to do, exceptions?
it uses healthy volunteers to see if the drug is safe with the exception of risky cancer drugs. checks tolerated and safe doses. movement of drug (absorption, distribution, metabolism)
how do you join phase 1
contract research organnization, hospitals
how is phase 2 dosing guided
results from phase 1
biomarker
indirect markers of internal state, objectively
what is a serious ae
serious undesirable experience including death, hospitalization
how is pharmokinetic testing done in phase 1
frequent blood and urine tests to see how its moving, absorbed, eliminated
why did people die in 2016 phase 1 clinical trial disaster and how to avoid
due to accumulation because it happened on fifth day. a tougher selection process is needed
benefits of phase 2 trial participation
having health monitored more often than phase 1, altruism
risks of phase 2
stop other meds, could be dangerous and could make things worse. might not be able to be in future trials, do not know who is getting experimental, changes in lifestyle, stigma?
why do you need inclusion criteria
to make sure people in trial are similar enough
what is washout period
waiting for body to get rid of other drugs
what phases are focused on testing for efficacy
2 and 3
what are qualities of a good biomarker
sensitivity (accurately say people with disease are sick) and specificity (accurately say people without disease are healthy)
what are difference between medical signs and symptoms
signs are things you can observe about patient, symptoms are what the patients feel.
what happens after trial
may be told what treatment and what the treatment was after you finish, after some time. code break only after everyone is done, and exit interview for everyone asap. will recieve results of overall trial. keep in touch to see long term symptoms
how many patients are in phase 3
thousands
what phase is drug approval based on
phase 3
what does health canada evaluate to make a decision
safety, efficacy, quality
what can you do if your drug is refused
provide extra info, resubmit later with extra data, appeal.
what does the AIDS activists want
to shorten drug approval process, no more double blind, include affected populations in all stages (need people of different HIV infection stages)
what happened around 1990 about aids
drugs were passed even though some trials were not complete, organizations worked together to go faster
what populations are restricted in first 3 stages
young and old, people with mild and severe condition, comorbidities, pregnant people, ethnicities may not be representative
what is different about phase 4 regarding monitoring
more intense monitoring
what does phase 4 look for
safety over time, quality of life, cost effectiveness
what are reasons for recall
drug manufacturing/purity, mild and major effects. can be years later than release
what are EUAs
increase avaliability of unapproved mediation, or approved for unapproved uses
where is off label meds common
oncology, pediatrics, elderly
what is potency
how much drug is needed to get required effect
what is IC50
a common way to measure potency, concentration at which inhibition is 50% of the maximum effect
what is a common potency for approved drugs
20 nanomolar (low nanomolar)
what is a sub nanomolar potency drug and what is a high micromolar potency drug
subnano is scary like botox, high micro is bad cuz not potent enough
what are flavonoids
chemical junk that don’t work below 500nm, from sources you would expect to be healthy
how does botox not kill you
it doesn’t go anywhere else than the face
most widely prescribed drugs are big or small molecules
small molecules
what two traits do antibiotics need
selectivity and permeability
how much lower is infectious deaths in developed world than developing
40%
what is predicted to be the path of drug resistance bt 2050
10 million lives lost due to resistance to infectious diseases
when was antibiotic resistance first mentioned, examples of us procrastinating about this?
- sars drug could be used for covid but we did not
how many people did tuberculosis kill
1 in 7 people that ever lived
when did discovery void for antibiotics happen
1987ish