Pharmacology I Flashcards
(150 cards)
T/F
Chinese developed drugs in 2700 BC in Doctrine of Signatures. The oldest prescription is on a Sumerian Tablet around 3000 BC.
True
T/F
Hippocrates big insight was that disease is from natural causes.
True
What was the 1st specific drug used to treat a specific disease?
Quinine from Peruvian Tree bark used to treat Malaria
What is the single most important drug discovery in medicine?
Acetylsalicylic Acid - aspirin - 1890’s
What treatment/drug for Congestive Heart Failure is still isolated from the Foxglove plant?
Digitalis
How are arsenicals made?
Arsenic to Carbon atom attachment
What 2 Alkaloid substances were isolated from Atropa belladonna?
Atropine (pupil dilator)
Scopolamine (motion sickness)
T/F
Penicillin was used in WWI
False
not until WWII
How long does it take to develop and bring a new drug to market?
How much does it cost?
15 years
360 million
____ out of 10 compounds that are developed reach market.
Of those, ___ out of 10 have ROI.
2
3
How long does a Patent for a new drug last?
17 years
Define Margin of Safety:
LD50 divided by ED50
lethal dose/effective dose
What is an acceptable Margin of Safety?
2000 or more
Animal Testing and Margin of Safety (LD50/ED50) are part of ______ Testing
Short-term Toxicity
What is another name for Long-term toxicity studies?
Chronic Toxicity Studies
T/F
Chronic Toxicity Studies involve daily dosing of dogs/rats from 3 months to 2 years, than animals are killed and histopathology is studied
True
What are 2 Specialized animal studies done for Safety?
Reproduction (teratogen)
Carcinogenicity
What can be submitted if drug has adequate margin of safety in rats, there are no long-term toxicities, no carcinogenic effects, non-teatogenic?
What is the Approval Time?
IND - Investigational New Drug Application
30 days
In what phase are drugs evaluated in humans for the 1st time?
When does it begin?
Clinical Studies - Phase 1
Immediately after IND approval
Who is studied in Phase 1?
20-80 healthy male humans
What is determined in Clinical Studies - Phase 1?
3 things
Safety Profile
Pharmokinetics
Toxicity dose
At what clinical phase of the study are new drugs given to patients that have the condition for which the drug is intended?
Phase 2
How many subjects are in Phase 2 studies?
What is determined?
100-300 subjects
Short-term effectiveness
T/F
Phase 1 establishes therapeutic efficacy, dose response/range, metabolism, and adverse drug events.
False
*Phase 2