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i fucking hate pcl > finals AAAAAAAAAAAAAAAAAAAAAAA > Flashcards

finals AAAAAAAAAAAAAAAAAAAAAAA Flashcards

1
Q

How many years for preclinical testing, what is the test population, purpose and success rate

A

6.5 years, lab and animal studies to assess safety, biological activity and formulations. 5000 compounds evaluated

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2
Q

How many years for phase 1, what is the test population, purpose

A

1.5 years, 20 to 100 healthy volunteers to determine safety and dosage

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3
Q

How many years for phase 2, what is the test population, purpose

A

100 to 500 patient volunteers to evaluate effectiveness and look for side effects

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4
Q

How many years for phase 3, what is the test population, purpose

A

1000 to 5000 patient volunteers to confirm effectiveness, monitor adverse reactions from long term use, to compare efficacy of new treatment with standard regimen

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5
Q

When do you need to get FDA approval

A

After preclinical and after phase 3

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6
Q

How long does it take for the FDA to finally approve and how many drugs make it (out of how many)

A

1.5 years after phase 3. it takes a total of 15 years and only one drug is approved from the 5 that enter clinical trials

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7
Q

Why do cancer cells reproduce infinitely

A

Growth machinery is activated or stop machinery is gone. This is often a genetic change, with the DNA being different from healthy cells

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8
Q

What kind of mutations are passed on

A

inherited but not acquired mutations, because acquired or somatic mutations are not in the egg or sperm cells

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9
Q

What mutations cause cancer

A

acquired lol, i’m going to die because of my constant exposure to chemicals and possible carcinogens due to cosplay

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10
Q

What is the newer type of cancer drugs

A

Targeted therapy

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11
Q

What are the two components of human immune system

A

Innate and acquired immunity

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12
Q

What do t cells do

A

They are a type of immune cell that bind foreign peptides to kill cancer cells

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13
Q

What do b cells do

A

They have the ability to create antibodies, which kill cancer

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14
Q

How does cancer evade our immune systems

A

Cancer can turn off immune cells, change the healthy cells in tissue around tumor, and alters how immune system deals with cancer cell

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15
Q

What is immunotherapy

A

A therapy that helps our immune system overcome the ways cancer evades it

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16
Q

How did deidra williams get cured in first in human

A

first remove own hemotopoietic stem cells by chemo then deliver family member’s stem cells

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17
Q

How many drugs are marketed in north america

A

1000

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18
Q

How many prescriptions per year in the US

A

3.4 billion

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19
Q

How many hospital visits need drug therapy

A

75%

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20
Q

What does the who list of essential medicines take into account

A

how common the disease is, how serious is the disease, public health, community health, efficacy, cost effectiveness

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21
Q

What is a drug target

A

a molecule that the drug binds to that deactivates the molecule, usually a protein. It needs to bind specifically.

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22
Q

How many animal species to test on in drug discovery

A

2

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23
Q

In what cases do you have patients in phase 1

A

Cancer patients

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24
Q

When is pharmokinetics investigated

A

phase 1

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25
Q

When was the flu pandemic and how many people did it kill

A

1918, 50 to 100 million people

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26
Q

When were the first smallpox vaccinations made

A

1796

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27
Q

Who was Galen

A

physician who proposed that we release humors with bleeding and purging

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28
Q

Why did the polypharmacists screw up

A

because plants are generally bad medicine (chinese medicine: lol)

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29
Q

What were the differences between galen, and paracelcus

A

galen was a polypharmacist who believed in random bullshit go, said disease was from internal imbalance. paracelcus said that disease was from an outside source and monopharmacy (是药三分毒）

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30
Q

Why did monopharmacy favor minerals and metals

A

They were easier to purify

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31
Q

Why the fuck did people hate alchemists that shit is cool as fuck creation is mutilation to the uneducated

A

fuck you bitch

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32
Q

Christopher columbus fucked a manatee and then what happened

A

people got syphillis and then you need to be wrapped in mercury blanket and sweat for 10 days

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33
Q

What were the plants that are actually medicinally useful

A

opium, quinine, and digitalis. Quinine and digitalis were respectively discovered 1600s to 1200s

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34
Q

How does the extraction of pharmologically active substances advance science

A

allowed 1806 discovery of morphine, which then turned into diamorphine

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35
Q

How did the dye industry benefit drug discovery industry

A

Dyes stained neurons allowing scientists to study them, and also allowed for the discovery of atoxyl, an arsenic drug for syphillis. They discovered chrysoidine which was a red dye that had activity against streptococci

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36
Q

What drug followed arsenic drugs

A

penicillin

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37
Q

When is the golden age of drug discovery

A

1944

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38
Q

Why are proteins the common drug targets

A

DNA and RNA are hard to find potent compounds, lipids have low specificity, carbs have toxicity

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39
Q

What types of proteins are common drug targets

A

Enzymes and receptors

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40
Q

What fits into the active site of the enzyme

A

Substrates but the products do not fit

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41
Q

What is genomics

A

study of genes in genome and interactions among them and environment

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42
Q

What is genetics

A

Study of single genes in isolation

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43
Q

What do cancer genome changes reveal about drugs

A

Reveal possible drug targets for target identification

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44
Q

What is target validation

A

Does the identified protein matter to the mechanism of the disease

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45
Q

What are SNPs what do they do

A

single nucleotide polymorphisms that change appearance, risk for certain diseases, responses to drugs, or can have no effect

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46
Q

How do SNPs contribute to type 2 diabetes

A

Several SNPs have been associated with a slightly increased risk for type 2 diabetes

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47
Q

How are SNPs that cause disease identified

A

comparing DNA from patient with healthy individuals, finding differences. This can be used to determine risk for the disease and identify drug target

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48
Q

What are personal genome projects

A

sequence many people and correlate sequence to health status

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49
Q

What type of target is identified but not validied

A

When there are possible target genes but its unclear whether or not he genes protein product actually does something for the disease

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50
Q

How can you validate genes

A

Test with model organisms to see behavior, or use human cells to see changes in behavior like cell growth and cell death.

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51
Q

What are the goals of translational medicene

A

Identify and invent diagnostic tests, drug and therapeutic development and clinical impact

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52
Q

What are the three Rs in animal research

A

replacement, reduction, refinement

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53
Q

What is xenographing

A

Put human tumors into mice that are immunocompromised, so the tumor can be measured and monitored

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54
Q

What is ALS

A

a progressive and fatal disease that cause motor neurons to break down

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55
Q

How were ALS drugs discovered

A

Using C. elegans model of motor neuron disease to mimic the genetic cause of ALS

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56
Q

How is anxiety measured in mice

A

Anxiety medicine reduces amount of time spent in enclused area. Mice prefer dark and enclosed spaces so they would stick to the side of open fields and stay in the dark side of a light/dark box

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57
Q

How long do animal models need to be tested for in preclinical

A

6 months to 1 year

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58
Q

How do people need to make sure the animal testing is sufficient for human trials

A

Exaggerated dosing, exaggerated exposure length relative to clinical use

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59
Q

What are types of toxicity end points

A

Death of proportion of cells/organisms, pathology using a microscope, surrogate measures of organ toxicity by measuring blood or urine.

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60
Q

What is lethal dose 50

A

it sounds like a really cool name for a tv show or character but really is just the dose to kill 50% of the cells or organism population. units are mg/kg

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61
Q

What questions do in vivo and in vitro experiments answer

A

in vivo is for living organisms and asks if a drug causes certain problems (safety concern). in vivo is in glass and can biochemical or cell culture experiments to see if the drug damages DNA of bacteria (indirect safety test)

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62
Q

What can cause toxicity

A

The drug or one of its metbolites

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63
Q

What is an ames assay

A

Using a strain of bacteria genetically modified to need histidine, if bacteria mutates then the bacteria will be able to grow without histidine. The more growing without histidine, the more mutated

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64
Q

What are the major target organs for toxicity

A

All major organs

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65
Q

How are stem cell used for drug safety testing

A

Human stem cell derived heart cells are put through high throughput tests

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66
Q

What are biomarkers

A

indirect markers of internal state measured objectively. for example if the liver bursts and releases liver specific enzymes

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67
Q

What are the undesired effects considered by toxicology

A

Allergic reactions, reactivity to standard dose, reversible and irreversible effects, local and systemic effects

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68
Q

why does clinical research need value

A

To use finite resources responsibly and avoid exploitation

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69
Q

What is clinical equipoise

A

to be uncertain about whether new treatment is superior or not

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70
Q

What are REBs

A

Research ethics boards that can be institutional or independent, investigator must submit detailed applications to the local REB for approval

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71
Q

What is a multiple ascending dose study

A

testing a dosage over many days to see if it accumulates

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72
Q

How do you participate in phase 1 clinical trials

A

contact contract research organization or hospital where the trial is being conducted

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73
Q

What features of a drug does pharmacokinetics consider

A

Absorption, distribution, metabolism, elimination

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74
Q

What are serious adverse events

A

Death, life threatening, hospitalization, disability, birth defects, needing invervention to prevent any of the above

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75
Q

What is a washout period

A

a period of time when you wait for previous drugs to be flushed out of your body

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76
Q

What is sensitivity

A

fraction of people i think are gay. if i have a high sensitivity gaydar, that means i always categorize gay people as gay (this is true)

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77
Q

What is specificity

A

fraction of people i think as not gay. if i have a low specificity gaydar, that means i may categorize straight people as gay (this is true)

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78
Q

What are medical signs, differences with symptoms

A

Signs are objective indications of medical state observed from outside the patient. Biomarkers are an example.

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79
Q

What are medical signs and whats the difference with symptoms

A

signs are objective indications of medical state observed from outside the patient, like biomarkers. medical symptoms are indications of health or illnness percieved by patients themselves

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80
Q

How do people know in phase 2 that a drug is effective

A

By using biomarkers. Phase 2 trials are relatively short in duration so biomarkers are relatively well suited for this timeframe

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81
Q

For HIV and AIDs drugs, what are the common biomarkers

A

Viral load (blood test), high viral load is bad. CD4 cell count. If there is a high number, that is good

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82
Q

What does lurasidone affect (neurotransmitter receptors)

A

dopamine d2 and serotonin receptor, agonist actions at both

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83
Q

What does lurasidone aim to alleviate

A

schizophrenia and bipolar. It can be used monotherapy for bipolar depression or adjunctive therapy for bipolar 1

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84
Q

How many people are affected by bipolar, when is the onset

A

3% of the us patients and 60 million worldwide. The onset is 15-25

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85
Q

How many people are affected by schizophrenia, when is the onset

A

1% of world population, early onset is late teens and early 20s

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86
Q

What are the doses for phase 1-3 lurasidone

A

for 1, they did 40 and 120 mg, for trial 2 they did 20, 40, 80. They determined 80 as the most effective for 3.

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87
Q

What is potency

A

how much drug needed for required affect

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88
Q

What is IC50, why is it used

A

concentration at which there is 50% max effect. the differences are more significant than 100% or 0% potency

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89
Q

What do different potencies of drugs indicate

A

Sub nM is scary, low nM is good, high nM is not that good. Low milimoles is bad and high milimoles is you failure lol

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90
Q

What are flavonoids

A

chemical junk from natural sources that seem healthy but don’t actually do anything

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91
Q

Why is selectivity important

A

it separates drug from poison because you are preventing the drug from going where it should not. However, not all drugs have this

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92
Q

Are most of our drugs small or biologics

A

Small

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93
Q

How many people could drug resistance kill by 2050

A

10 million lives

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94
Q

Why is tuberculosis still a problem

A

Drug resistance turboculosis has a high cure rate but multi drug restance has a 48% cure rate (basically a 50/50, and considering i won all my genshin ones, its o7 for me lol 没保底了) for extensively drug resistant ones, the cure rate is 34%

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95
Q

Where do antibiotics come from

A

natural products and screening

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96
Q

What is the biggest problem with dealing with bacteria

A

Permeability, selectivity isn’t too hard because humans are fundamentally quite different from bacteria. You need to get through a barrier with the consistency of candle wax

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97
Q

Is it impossible to find man mane antibiotics

A

No, we have cipro, but permeability is hard.

98
Q

How to target a protein or other target on something not as simple as bacteria?

A

Some ATP bind loosely to binding sites, creating differences between amino acid sequences. more binding interactions will prevent it from fitting into too many receptors

99
Q

What can help us find how to better bind to a target

A

crystal structures to tell us the structure

100
Q

How much selectivity does a highly potent drug have

A

200 fold sens

101
Q

How much sensitivity does a moderately potent drug have

A

less than 100 fold sens

102
Q

Why is the liver a pain in the butt

A

cytochrome p450s oxidise drugs and throws that shit out

103
Q

How long do you want drugs to be active and how do you keep it active

A

8 hours, achieved by adding fluorine

104
Q

Why do you need to understand metabolites

A

Taking too much would overwhelm normal metabolic route and the alternative metabolite route can be toxic

105
Q

What is bioavaliability

A

How much has survived, how much is absorbed in the gut, and how much got through the liver unscathed

106
Q

What does a large therapeutic window do

A

allow for more therapeutic responses without toxic ones

107
Q

What is the relationship between potency and solubility

A

The more potent the less likely solubility is an issue

108
Q

What types of drugs are best at dissolving in the digestive track

A

Polar and charged

109
Q

What can cause poor permeability

A

drug not getting through membrane or getting kicked out

110
Q

After target validation, how do we find what chemicals bind to the protein and change the function

A

high throughput screening, fragment screening, in silico screening

111
Q

What are undruggable targets

A

targets that have nothing to guide us towards

112
Q

What do you test chemicals on in high throughput screening

A

enzymes, cells expressing a certain pathway, and on model organisms

113
Q

What is target based screening

A

With a known target you look for chemicals that moducate the target or pathway

114
Q

What is phenotypic screening

A

Only looking for the desired effect

115
Q

How can phenotypic screening be more complex than the killing of bacteria

A

You can look at zebrafish, which are tiny, transparent, easily grown

116
Q

What is fragment screening

A

Looking at a library of fragments to combine it to give one full compound

117
Q

What is activity of a drug

A

What a drug does (blocks a receptor, for example)

118
Q

What is efficacy

A

if it will actually work

119
Q

Why is it good to have potent drugs

A

generally less toxicity, less solubility, and less permeability problems

120
Q

What is on target toxicity

A

if activating the target will also cause problems, potency won’t help this scenario

121
Q

What is a pharmacore

A

part of the structure that bind to the target

122
Q

how does a pharmacore bind

A

electronic properties as long as the same bonds form its ok

123
Q

what does structural extension do

A

increasing potency by finding extra binding interactions

124
Q

what does rigidification do

A

increase potency and selectivity

125
Q

Are osteoblasts or clasts more common when we are younger

A

blasts

126
Q

what do you use for a phenotypic screen

A

cells instead of targets because you do not know how the drug wors

127
Q

what is admet

A

absorption, distribution metabolism, excretion, and toxicology

128
Q

what is the minimum concentration you need to stay above for many diseases

A

50 nm

129
Q

Why do you need higher concentrations than estimated

A

blood proteins will yoink the proteins

130
Q

what do permeability assays measure

A

rate at which a compound passes through a layer of cells

131
Q

how good does permeability need to be

A

96% of drugs that act on the brain have >150 nm/sec permeability

132
Q

why is the brain and bacteria and cancer cells good at yeeting stuff out

A

p glycoprotein that is an efflux pump. pretty much everything binds to it

133
Q

what is the efflux ratio, how much is bad

A

permeability out/permeability in. twice as fast kicked out as going in is bad

134
Q

when is a drug determined too expensive

A

over 30000 pounds per year, but anything over 15000 is harmful because it takes money away from essential healthcare services

135
Q

how much is the most expensive drug, how good is it

A

3.2 million and it doesn’t do much

136
Q

what justifies the high prices of the drug discovery industry

A

no other industry has such a high risk of failure, only 5-10% of drugs that enter clinical trials reach the market, only 1 in 3 make a profit. it costs a lot to make drugs and a lot to market

137
Q

what happens if a pharma company is not profitable

A

share price goes down, management fired, company taken over, employees fired

138
Q

what happens if pharma is too expensive

A

some companies may reject the patent

139
Q

when did drugs turn into commodities

A

early 1980s

140
Q

When did aids have a first improvement in survival and when was life expectancy normal

A

improvement was 1995, normal life expectancy was 2007

141
Q

what could have happened with HIV and why didn’t it

A

HIV could be eliminated within a generation but poor ART coverage prevented it and fewer than half the people infected got treatment

142
Q

why did fda approve the expensive alzheimer’s drug

A

so other people can be motivated to make better ones

143
Q

how do people make alzheimers drug discovery better

A

remove money from the equation, force collaboration and open source

144
Q

how are pharmaceuticals made more affordable in the developing world

A

patent pools and having rich people donate, no longer pursuing drugs that don’t work that well to prevent phase 3 failures and lower developmental costs. emphasize deisease prevention, detection and diagnosis. link price with GDP and remove advertising from pharmaceuticals

145
Q

what does gartners hype cycle say

A

overreaction to immature tech causes naive euphoria, then peak of hype and true user benefits become apparent

146
Q

what makes a target undraggable

A

if the drug only has weak binding interactions with a target

147
Q

why is it hard to find a target

A

cannot find clear differences between healthy and unhealthy people. hitting a single target may not cure the disease, and ideal target may be essential to other aspects of health

148
Q

why do you need both lipophilic and polar residues for a druggable target

A

to get to the target and bind to it

149
Q

what happened with drug discovery 1900 to 2000

A

develop drugs from what we have and know, get lucky, talented people free from corporate, anything you make is potentially exciting

150
Q

how do you get selectivity on adrenoceptors

A

make subtle changes because they are all slightly different in shape and size

151
Q

why is it hard to find drugs fromnature

A

need extraction, there might be various components and have weak activity. might not be possible to get enough from original source

152
Q

what percent of drugs come from nature

A

6% are natural products, 28% are modified natural products, 30% mimic natural products

153
Q

what is type 2 diabetes

A

high blood sugar and insulin resistance that causes blindness, kidney failure, heart attacks, strokes etc

154
Q

why is obesity a problem

A

50% of world population will be overweight or obese in 2035 unless action is taken, children most affected. very expensive too

155
Q

what drives obesity

A

dietary preferences, sedentary behavior, weaker policies to control food supply and marketing, not enough resources for weight management and education

156
Q

What other diseases does obesity influence

A

depression and arthritis

157
Q

what drugs were used for weight loss in the 1950s-1960

A

amphetamines that caused addiction

158
Q

what happened with fen fen

A

obesity drug recall after 24years because it damages heart valves. one of the most costly liability cases in history

159
Q

how does glp1 regulate insulin levels

A

stimulates insulin secretion and inhibits glucagon secretion to have 2 shots on goal

160
Q

why do you need gila monsters for diabetic medicine

A

human glp-1 hormone disappears too quick, but gila monster can go for a long time without food indicating slow digestion

161
Q

what diseases has glp endocrine processes helped understand

A

type 2 diabetes, obesity, short bowel syndrome. also propelled the research of neurodegenerative conditions like alzheimers parkinsons and huntingtons

162
Q

what happened in early clinical studies testing glp 1

A

people were supposed to eat after treating with glp then check blood glucose. people didn’t want to finish their meal and had low appetite, and thus the clinical study can’t be followed

163
Q

how are glp agonists different from glp 1

A

change in amino acids, prevent degredation of peptide, clues from nature

164
Q

what did the phase 3 clinical trial with semaglutide conclude

A

people without diabetes who were overweight or obese had weight loss

165
Q

how are peptides taken

A

generally not orally, the peptide will be digested if taken orally. oral formulation is developed and mixed with absorption enhancer. needs to be on empty stomach

166
Q

for the oral semaglutide phase 3 tests, what was concluded about efficacy and side effects

A

lost 15% weight compared to 2.5% on placebo. GI problems for 80% people compared to 46% on placebo

167
Q

why do glps have side effects

A

may accidentally target brain

168
Q

what is food noise, how is it affected by glp

A

thinking frequently about food, glp reduces this

169
Q

what do coronaviruses cause

A

sars and mers and common cold

170
Q

what is R0

A

how contagious a disease is, average # of people who get sick from one infectious person

171
Q

what platforms are there for covid vaccines

A

viral vectors which carry virus into the host cell, DNA and RNA which carry genes into cells to make a protein for resistance. or just a protein. killed or attenuated virus that stimulate protein to recognize viruses.

172
Q

what is a viral vector

A

modified viruses that deliver genetic code for antigen but do not contain disease causing genes. it can be broken into replicating and nonreplicating types

173
Q

why did people not find a treatment for sars even though another viral disease would happen sooner or later

A

development was helted when virus was gone, no commercial reason to continue

174
Q

what is the sped up covid trial process

A

used preexisting data from sars, do the clinical phases at once and produce at a risk (during phase 3)

175
Q

what is the comirnaty vaccine and spikevax vaccine

A

mRNA encodes spike protein enclosed in liquid nanoparticle, 2 doses 3 weeks apart

176
Q

what happened in phase 1 comirnaty vaccine

A

tested safety of 2 different vaccine candidates.

177
Q

what happened in phase 2 and 3 of the two covid vaccines

A

tested on 300 and 600 adults. evaluated efficacy against placebo with multiple dosage. chose one dosage for phase 3

178
Q

what is medicago’s plant based vaccine

A

virus like particles made in plants, harvested and purified. it is 71% efficacious against covid

179
Q

what is novovax

A

an old vaccine used for omicron, contains spike proteins from insect cells and immune system stimulant

180
Q

how are small molecule drugs discovered

A

repurposing drugs: using existing drug or preclinical chemical compound

181
Q

why is drug repurposing good

A

you might not need phase 1 retests, existing pharma supply chains could help make it

182
Q

what is a pharmakinetic booster

A

compound used with primary therapeutic agent that enhances the activity of primary agent, allows for lower dosage of primary agent. reduces pull burden and extent of toxic side effects

183
Q

what happened with paxlovid trials

A

stopped early due to benefit

184
Q

what is long covid

A

symptoms for more than 12 weeks after infection

185
Q

what percent of people experience long covid

A

15%

186
Q

what can long covid affect

A

heart, lungs, pancrease, immune system, GI tract, neurological system, kidney spleen liver, blood vessels, reproductive system

187
Q

what are possibilities for the causes of long covid

A

neurological signalling changes, bacteria in gut shifted from covid, immune cells are primed differently.

188
Q

what prevents long covid

A

vaccination against covid

189
Q

what is being tested for long covid clinical trials

A

antibodies, oral pills to treat heart rate, high salt diet.

190
Q

what is pharmocodynamics

A

biochemical pathways and physiological effects. drug efficacy, toxicity and choice of treatment (what the drug does in the body)

191
Q

what does pharmacokinetics concern

A

dose, delivery, dosage regimen

192
Q

what are pharmalogical consequences of drug metabolism

A

inactivation, activating pro drug to active product, maintenance of activity, and increased chemical reactivity

193
Q

what metabolizes small organic molecules

A

drug metabolizing enzymes

194
Q

what are her 2 receptors in breast cancer

A

receptors that make cells grow faster

195
Q

how does herceptin work

A

attach to her2 receptors to block from recieving growth signals

196
Q

use smoking to indicate the importance of personalized medicine

A

depending on nicotine metabolization rate, different treatments are suitable

197
Q

how to get info for personalized medicene regarding patient

A

genotype patient and thent he digital info becomes centralized

198
Q

what is the money challenge for personalized medicine

A

less money earned if drug is directed towards small subset of cancer patients

199
Q

why is personalized medicine important for hepatitis c

A

it is curable bud ifferent drugs for different genotypes, which differ accross the world. some work for all genotupes

200
Q

what is project gradient

A

explores link between genetic diversity and response to malaria and TB drugs

201
Q

where do biologics come from

A

the natural world

202
Q

what is the difference between small drugs and biologics

A

small drugs are chemically synthesized in lab, biologics are made from living cells or organisms. biologics are less easily characterized and has many critical process steps. they are often injected or infused and dispensed by doctors or hospitals, compared to by retail pharmacies

203
Q

what is the first peptide biologic

A

insulin

204
Q

what are allogenic and autologous cell therapies

A

allogenic is from another person, autologous is from yourself

205
Q

what does stem cell therapy aim to do for parkinsons

A

transplanted will form neural networks that restore motor and non motor function to patients

206
Q

what is an antibody

A

proteins that help us fight against pathogen. antigens on antibodies will bind to pathogens to eliminate it

207
Q

how is an antibody structured

A

as a y, with a variable region that recognizes antigen and constant region that determines how to destroy the antigen

208
Q

what are polyclonal and monoclonal antibodies

A

polyclonal are a complex mixture of antibodies that recognizes and binds to different areas on the antigen

209
Q

what are monoclonal antibodies

A

identical antibodies from a single antibody producing cell, only binds to specific site on the antigen

210
Q

why do you need antibody engineering and how do you do it

A

mouse antibodies may be different and cause adverse reactions or cytokines destory the antibodies. recombinant allows the mouse monochromal antibody to fuse with the human one

211
Q

what is the traditional treatment for snakebite

A

immunize horses and cows to produce antibodies

212
Q

what did mice tests reveal about snake bite antibodies

A

there is a window of opportunity and antivenoms are effective.

213
Q

what are the issues with biologics, good and bad

A

more selective than small molecules, less toxic, potential for immunotoxicity (unique biologic toxicity), and has a long half life. has high specificity but high cost

214
Q

what are common characteristics of specialty drugs

A

expensive, needs specialized handing, administration, for complex and rare diseases and often biologics. very profitable

215
Q

why are specialty drugs so expensive

A

more expensive to make, small target populations

216
Q

how does remicade stop autoimmune diseases

A

these diseases come from the immune system attacking itself. remicade inactivates the factor that causes inflammation

217
Q

what are biosimilars and how are they different from small molecule drug generics

A

similar to innovator with comparable quality efficacy and safety, but is not the exact same as the biologic. generics are considered bioequivalent

218
Q

for what diseases are gene diseases most effective, how is it effective

A

when the mechanism involves a single gene, it changes or adds a healthy copy of a gene to improve patient health

219
Q

how did they test gene therapy for eyes

A

used a naturally occuring viral vector with less people (because there isn’t enough). tested by making them do a maze in a low light environment

220
Q

how does crispr gene therapy seek to fix hemaglobin for sickle cell

A

they get gamma hemoglobin to replace beta

221
Q

what is different between gene therapy and small molecule drugs

A

gene therapies are expensive, potentially curative with possible side effects and have only few approvals

222
Q

what is esketamine and what does it do for depression

A

it is a rapid acting analogue of ketamine that affects neuroplasticity and is taken as a nasal spray under medical supervision with less suicidal side effects than SSRIs. The target is in neuron communication

223
Q

What is geprione and how is it better than traditional SSRIs

A

agonist at serotonin 1A and antagonist at serotonin 2A, has extended release and reduced side effects

224
Q

what is the forced swim test and what is the problem with it

A

mice swim for 5 min and sometimes give up, which is used to indicate depression. it is traditionally used to test antidepressant drugs but not used because you need to justify it.

225
Q

what are alternative tests for testing rodent depression

A

enjoyment of life by consumption of sugar water, healthy sleeping patterns and resilience to stress by interactions with a larger mouse

226
Q

why is antidepressant testing a pain in the butt

A

the drug may treat some subtypes of depression but not others. There is high variability in the patient population and high placebo response rates. not easy to measure with self reported, subjective responses.

227
Q

what did the psilocybin and niacin results indicate about psilocybin

A

that it is clinically significant in reducing depressive symptoms

228
Q

how does lsd help anxiety

A

serotonin 2a agonist that binds to dopamine d1 and d2. trip persists after the drug is gone. clinical trials did not observe bad trips. LSD is hard to make with high purity, so the high purity might have prevented bad trips.

229
Q

what are the benefits of LSD for anxiety

A

it is fast acting and has durable activity, with significant remission and less side effects. monotherapy works.

230
Q

what are the problems with drug research in pregnancy

A

need to weigh in health of mother and fetus. there are different physiology and pharmacology aspects and reproductive toxicology studies are expensive. most drugs don’t have enough safety data for pregnancy use

231
Q

what do fda pregnancy exposure registries do

A

collect info on women who used the drug and women who did not during pregnancy to update safety info

232
Q

what did postpartum depression drug approvals reveal about post partum depression

A

it is not the same as major depressive disorder and has different biology. it is active very quickly though

233
Q

what is the problem with having children in drug research

A

patient recruitment, consent, pharmokinetic differences in children, and ethical issues

234
Q

what happened in the cystic fibrosis test in children

A

unprecedented improvement in lung function and exciting prospect. both lung function and quality of life are improved.

235
Q

what is the pediatric exclusivity provision

A

FDA incentivizing to conduct pharmacokinetic studies in children trials, useful when the drug would pose a serious risk. generally millions of dollars in profits due to extended patent life.

236
Q

how do machines learn

A

you give examples, then the machine categorizes the stuff for you. you don’t provide the labels

237
Q

what is ineffable

A

when something is too great or extreme to be put into words

238
Q

how can ai help for in silico drug discovery

A

use known inhibitors to train the computers and predict a structure that will predict inhibitors and test chemicals in a lab

239
Q

how can ai help for identifying drug targets

A

using ai to study protein-protein interactions, seeing if drug repurposing could change this interaction. First find protein-protein interactions then see which are druggable

240
Q

what variables do you need to predict the pharmacokinetics of a drug

A

physiology (blood flow, body fat, etc), drug’s chemical properties, drug-specific clinical info. also other meds, food or empty stomach, disease status (limited organ function) and age

241
Q

how can clinical trials be conducted inside a computer

A

using things like hummod that creates 10000 variables

242
Q

what does trial pathfinder do

A

expand inclusion criteria for cancer clinical trials

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