Pharm Exam 1 --> Drug Development Flashcards
What was the first specific drug to treat an infectious disease? What did it treat?
Quinine in 1630. It was isolated from tree bark to treat malaria
What is the single most important drug discovery in medicine?
Aspirin in 1897 by Felix Hoffman who was working for Bayer. He converted Salicyclic acid to the acetyl derivative.
Chemical name also given for aspirin
Acetylsalicyclic acid
What was the first hormone isolated?
Epinephrine in 1901
Who accidentally discovered penicillin?
Alexander Fleming in 1927
When was the first clinical use of penicillin
In 1941 used in WWII
How long does a drug take to develop? How much does it cost?
15 years
$360 million, but may cost more
How long is a patent for new drug?
17 years
Only about how many in 10 new compounds successfully reach the market?
2 in 10
Describe Phase 1 of drug development and testing
Clinical Studies - Phase 1
- Begins immediately after IND approval
- Evaluates drug in humans for first time
- 20 to 80 healthy volunteers
- Study safety profile, determine pharmacokinetics
- Establishes dose at which toxicity appears
Describe Phase 2 of drug development and testing
Clinical studies - Phase 2
- Given to patients having condition for which drug is intended
- Approximately 100-300 subjects
- Study of short-term effectiveness
- Establishes therapeutic efficacy, dose response and dose range, kinetics, and metabolism
- Also studies adverse drug events
Describe Phase 3 of drug development and testing
Clinical studies - Phase 3
- Numbers range from 1000-3000
- Confirm drug safety and efficacy
- Long-term efficacy
- Try to detect adverse effects undetected in prior studies
- Trial design is always a randomized, double-blind Fernandez approved
Describe Phase 4 of drug development and testing
Clinical studies - Phase 4
- Occurs after FDA approval
- Drug is used by greater numbers of people than in previous studies
- Collect additional data to define side effects
- Drug can be pulled off market in new toxicities are uncovered
- Often, problems result in relabeling of the drug with new warning or precautions
Give a summary of each of the four phases
Phase 1 –> (20-80 people) Test for safety in “normals”
Phase 2 –> (several hundred people) Safety and effectiveness
Phase 3 –> (several thousand people) Safety, dosage, effectiveness, adverse events
Phase 4 –> Post-marketing surveillance for adverse event monitoring
Which phase studies the short-term effectiveness of a drug
Phase 2
Which phase establishes dose at which toxicity appears
Phase 1
Which phase evaluates drug in humans for first time
Phase 1
Which phase evaluates Long-term efficacy
Phase 3
Which phase studies Safety profile and determines pharmacokinetics
Phase 1
Which phase occurs after FDA approval
Phase 4
Which phase is given to patients having condition for which drug is intended
Phase 2
In which phase is the study a randomized, double-blind trial
Phase 3
Which phase establishes therapeutic efficacy, dose response and dose range, kinetics, and metabolism
Phase 2
What is the one problem with the trial design in Phase 3?
It is still a small number of subjects taking the drug for more than 3 to 6 months compared with the potential number who will take the drug long term
Describe the definition behind a Chemical name for a drug
When a drug is being investigated by a company, it is identified by this name, which is determined by its chemical structure.
Describe the definition behind a Generic name for a drug
Before any drug is marketed, it is given a generic name that becomes the “official” name of the drug
T or F, All drugs have one generic name and one brand (trade) name
False, They have one generic name, but can have many brand names (trade name)
T or F, Generic names are not capitalized
True
Describe the definition behind a Trade name for a drug
If the compound is found to be useful and will be marketed commercially, then the pharmaceutical company that discovered the drug gives the drug a trade name.
T or F, After 17 years, the patent expires allowing other companies to market the generic drug under a trade name of their choosing
True
How do you determine the margin of safety
LD50 divided by the ED50
LD=(lethal dose)
ED=(efficacious dose)
If LD50=10 mg and ED50=2 mg, what is the margin of safety? What does this tell us?
10/2 = 5
This mens that the lethal dose is only 5 times the effective dose
What is an acceptable margin of safety?
2000 or more
What piece of legislation created the FDA? What were the requirements that the FDA would oversee
1906 - Pure Food and Drug Act
- Drugs must meet standards of purity and quality
- Manufacturers must provide correct and truthful labeling
Which piece of legislation requires proof of a drug’s safety and purity
1938 Food, Drug and Cosmetic Act of 1938
-**This act was updated as the FDA Modernization Act of 1997
Which piece of legislation grants the FDA authority to determine which drugs may be sold without a prescription?
Durham-Humphrey Act of 1952
What piece of legislation requires proof of efficacy as well as safety for new drugs and drugs approved since 1938
1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act
Which piece of legislation says the FDA must demonstrate that a supplement is unsafe before taking action against it
Dietary Supplement Health and Education Act of 1994
Discuss the authority that the FDA has over OTC drugs and dietary supplements
- Dietary supplements cannot make therapeutic claims
2. Required to have the disclaimer: “this product is not intended to diagnose, treat, cure, or prevent any disease”
