Quiz 1 (From lect. 2) Flashcards
what is the doctrine of signatures
physical characteristics of plants and herbs indicate their potential therapeutic uses.
The idea is that plants and other natural substances have a “signature,” often related to their shape, color, texture, or smell, which signals their specific healing properties.
examples of the doctrine of signatures
Walnuts were good to cure ailments of the head because they had a perfect signature for the head
since they looked like the brain they are thought to help with cognitive abilities and brain related diseases
The holes in the leaves of Saint Johns Wort resemble pores of the skin and, therefore, can treat disease and wounds of the skin
beans are kidney shaped and they heal and help maintain kidney functions
In modern times, medicines are developed by chemical synthesis of compounds that have
biological activity
first successful drug used against malaria
quinine
what is quinine
some tree bark contains this
still used today as drug of choice against malaria
first specific drug used to treat an infectious disease
arsenic is a poison
true
vSynthesis of arsenicals
attached arsenic atom to a carbon atom to synthesize arsenicals
led to use of arsphenamine to treat syphilis
led to use of arsphenamine to treat syphilis
synthesis of arsenicals
what lead ot digitalis
use of purple foxglove aka digitalis purpurea
lead to isolation of digitalis
tea was made to treat edema of cardiac dropsy (congestive heart failure)
drug of choice for congestive heart failure
digitalis
drug is still isolated from plants digitalis lanata leaves rather than digitalis purpurea seeds) because it is too difficult and expensive to synthesize chemically
true
digitalis drug
the way we regulated morphine from poppy seeds was the same technique to regulate caffeine
true
isolation of morphine lead the way for isolation of
caffein, atropine & strychnine
growth of poppy plants for medicinal use in US is not regulated
false, highly regulated
narcotic, used for pain control
opium
what is the source of optium
poppy plant (Papavir somniferum)
how did isolation of morphine come about
The poppy plant, Papaver somniferum, that produces opium, a powerful narcotic whose derivatives include morphine, codeine, heroin, and oxycodone.
history of coffee goes at least as far back as the
13th century
original native population of coffee is thought to have come from_______specifically from ______
East Africa
Ethiopia
first cultivated by Arabs from the 14th century and onward
caffeine/coffee
caffeine process
extracted from the coffee plant, Coffea arabica
Caffeine works by stimulating the CNS, heart, and muscles
It relieves mental and physical fatigue and increases mental alertness
The entire plant is extremely poisonous
Atropa belladonna (Devil’s cherries)
devils cherries
Atropa belladonna (Devil’s cherries)
belladona means
an enchantress of exceeding loveliness
what aer the 2 alkaloid substances isolated from Atropa belladonna
atropin
scopolamine
what is atropin
dilates pupils
after fall to injury or sprained part belladona plasters are applied
ingestion in access is poisonous
what is scopolamine
(from japanese belladona) - motion sickness (transderm patch), sedative, truth serum & mydriasis (prolonged/excessive pupil dilation)
source of silicin
willow bark
how is salicylic acid metabolized
a source of slicin is willow bark
this metabolizes to salicylic acid in the body
chemical precursors to aspirin
salicin & salicylic acid
N-acetyl salicylic acid
aspirin
what is aspiring
popular analgesic/anti-inflammatory agent
how salicylic acid is formed
willow bark to get silicin
salicylic acid is converted to acetyl derivative (acetylsalicylic acid)
willow bark and salicylates increase risk of
bleeding
ulcers
tinnitus
father of modern pharmacology
john jacob abel
first hormone to be isolated
epinephrine (adrenaline)
where is epinephrine produced
Some neurons of the CNS
The chromaffin cells of the adrenal medulla from the amino acids, phenylalanine and tyrosine
what is in the epipens?
epinephrine
only NT used in motor division of somatic nervous system
acetylcholine
what is acetylcholine
one of many NT in ANS
acts on CNS & PNS
has inhibitory effect in cardiac tissue to lower heart rate but is excitatory at neuromuscular junctions in skeletal muscle
first effective treatments for pneumonia, meningitis, & other bacterial diseases
sulfanilamide
discovery of sulfa
dye had no antibacterial effect butchanging its chemical makeup slightly allowed it to arrest infections in mice caused by streptococcal bacteria
found this active antibacterial portion of the dye naming it sulfanilamide (one of the first antibiotics)
sulfa powder & tablets - carried during WWII to reduce mortality
true
sulfa today
treat urinary tract infections
sulfa drugs pre-dated clinical use of
penicillin
what is prontosil
red dye
penicillin discovery
discovered accidentally - mold know mas penicillium notatum inhibited growth of staphylococcus aureus (bacteria) in petri dish in a lab
was named penicillin
used in WWII to save lives and is why penicillin production occurred in the US
past was a tea, derived from foxgloves, used for congestive heart failure
digitalis
from tree bark, used against malaria
quinine
arsenic atom attached to a carbon atom; arsphenamine to treat syphilis
syphillis
poppy plant (Papavir somniferum) that produces poppies, opium is derived from poppy sap, morphine is then an active alkaloid found in opium
used to treat pain
isolation of morphine lead the way for isolation of caffein, atropine & strychnine
morphine
extracted from the coffee plant, Coffea arabica
stimulates the CNS, heart, and muscles
relieves mental and physical fatigue and increases mental alertness
caffeine
atropine (eye dilation) & scopoline (sedative & motion sickness - transderm patch)
Atropa belladonna (Devil’s Cherries)
silicin from willow bark, turns into slicylic acid in body (both are precursors to aspirin/acetylsalicylic acid)
salicylic acid
increase risk of bleeding, ulcers & tinnitus
willow bark & salicylates
used for severe allergic reactions
epinephrine/adrenaline (1st discovered) (also NT)
excites skeletal muscles & lowers heart rate (CNS & PNS & found in ANS)
acetylcholine (also NT)
first antibiotic (sulfanilamide) that cured streptococcal bacterial infections (first effective treatment for pneumonia, meningitis & other bacterial diseases)
for urinary tract infections, reduced mortality in WWII & pre-dated clinical use of penicillin
sulfa
found in mold (penicillium notatum) that stopped staphylococcus aureus bacteria
produced in US due to saving lives in WWII
penicillin
what is the FDA
regulatory agency involved in regulation of drug development
what is the purpose of the FDA
regulates food , drugs , cosmetics , OTC , supplements , drug dev, controlled substances (tobacco, sedatives , addictives , stimulants)
why does the FDA have stronger rules
due to the Strep-Elixir - killed people by mixing drug molecule with antifreeze
what is the FDA exemption law
allows FDA to permit off label use, and it was after the AIDS crisis
why we were able to make covid vaccine fast
permit pharmaceutical companies to broaden access to investigational products while they are still going through clinical trials
what does the modern fda protect
public health by ensuring safety and effictiveness of meds, biological products, med devices, food, cosmetics, and radiation emitting products
what does the modern fda advance
public health by accelerating innovations for more effective safer and affordable meds while providing public with accurate science-based info for better health
approx ____ billion to produce new drug
$1-$2
approx _____ years
12
______ drugs make it to market
1/10
what are the phases of drug development
discovery
development
clinical studies
post marketing surveillance
what happens in discovery phase
Discover molecule & file patent
what happens during development phase
short term toxicity w/ animals (LD50 & ED50 & MOS)
long term toxicity w/ specialized animals (reproductive & cancers), submit IND
what is LD50
determine lethal dose - LD50 (50% out of total receiving drug dose are killed)
what is ED50
determine effective dose - ED50 (50% out of total receiving drug dose causes an effect)
What is the margin of safety
LD50 ÷ ED50
acceptable margin in drugs is >/= 2000
LD50 = 10 mg
ED50 = 2 mg
what is mOS & what it means
MoS = 5
legal dose is only 5x the effective which is low margin of safety in humans
what happens in phase 1
immediately after IND approval, 20-100 healthy individuals, non-blinded (participant & tester know) takes several months (shorter time), purpose is for safety, pharmocokinetics (what does the body do with the drug) & pharmacodynamics (how does it affect the body), tested for safety in volunteers
waht happens in phase 2
up to several hundred diverse individuals with the disease, 1-4 yrs, purpose is for short-term effectiveness, safety, and dose ranging; double blind (random assignment, neither party knows)
what happens in phase 3
several hundred to several thousand taking drugs, 1-4 years, toxicities here may not show until after marketing when millions take it long term, testing for safety, dosage, effectiveness & adverse effects
submit NDA after conclusion of clinical trials (approx 8-9yrs after animal & human testing), if approved can sell
true
what is phase 4
post marketing surveillance for adverse event monitoring forever
after FDA approval
monitored for remainder of life span
can be pulled off market or relabeled with new warnings and precautions
wht is the right to try law
allows terminally ill patients to access experimental treatments that have passed Phase I of clinical trials but have not yet been approved by the Food and Drug Administration (FDA).
This legislation aims to give patients who have exhausted other treatment options the opportunity to try investigational drugs that could potentially help them, without waiting for the lengthy FDA approval process
chemical drug name
determined by chemical structure; ex: acetylsalicylic acid
generic drug name
not capatalized, FDA approved official name
brand/trade name
trademarked
What is ANDA?
abbreviated - application for drug approval for an existing licensed medication or approved drug
what is NDA
new drug application - submitted after successful conclusion of clinical trials approx 8-9 yrs after animal and human testing
What is a Patent?
lasts approx 20 yrs after applying prior to phase 1 of testing
other companies can file ANDA to sell the same product without clinical trial testing
gives the patent holder the exclusive right to manufacture, use, sell, and distribute the drug for a certain period, typically 20 years from the date of filing
ex of patent and ANDA
ibuprofen is the generic name (note the small case lettering)
After patent expiration, the trade names for ibuprofen include
Advil
Caldolor
Genpril
I-Prin
Ibu-200
Midol Cramp and Body Aches
Motrin; Motrin Children’s, Motrin Junior, Motrin IB
Neoprofen
Factors affecting drug cost and drug development
research & devleopment costs
includes FDA approval process
complicated manufacturing process
coverage and reimbursement for the drug by 3rd party payer (insurance)
desired profit margin of manufacturer
maximizing profits prior to patent expiration
export to other countries
determined by foreign government or negotiation
usually lower over seas
what is the difference bw pharmacology and pharmacoepidemiology
pharmacology - basic and clinical applied science that deals with fate and actions of drugs in the body
pharmakon - poison or drugs
logos - study or discourse of
pharmacoepidemiology - study of drug outcomes
study of the use and effects of drugs in large populations
Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.
basic and clinical applied science that deals with fate and actions of drugs in the body
pharmacology
study of drug outcomes
pharmacoepidemiology
study of the use and effects of drugs in large populations
pharmacoepidemiology
Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.
Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.
how early are they able to ask for a patent?
right after or before they find the molecule, during phase 1
what is the avg time
12 yrs (8-15)
