Drug Development and Herbals Flashcards
What is a biologic? Most common example of a biologic?
Substance used to replace something that is naturally already there
Insulin
Two major components of pre-clinical testing.
What do you call a substance that makes it through
In vitro studies and animal testing
Investigational New Drug
What are you trying to determine in Phase 1 clinical testing? How many subjects?
Is it safe? Pharmacokinetics?
20-100 Subjects
What are you trying to determine in Phase 2 clinical testing? How many subjects?
Does it work in patients?
100-200 patients
What are you trying to determine in Phase 3 clinical testing? How many subjects?
Does it work? Double blind
1,000-6,000
If the clinical testing phase is successfully completed, what happens next?
New Drug Application
A successful drug takes about __ years to get tom concept to marketing.
15
Discoverers of cholesterol synthesis?
Brown and Goldstein
Significance of the Pure Food and Drug Act (1906)
Insures purity and proper labeling
Significance of Federal Food, Drug, and Cosmetic Act (1938)
Required FDA toxicity studies
Significance of the Kefauver-Harris Amendments (1962)
Required proof of efficacy
established guidelines for reporting adverse effects, clinical testing, and advertising
FDA authority over maufacturing
Significance of the FDA modernization Act (1997)
Expedited review for drugs for serious diseases
Indication for taking St. John’s Wort
Mild/Moderate Depression
Active Ingredients of St. Join’s Wort?
Hyperforin, Hypericin
Potential drug interactions of St. John’s Wort?
It induces CYP 3A4, 2C9, and P-gp
This can speed up breakdown of other drugs (like contraceptives)
Potential side effect(s) of St. John’s Wort?
Photosensitivity
Indication for Echinacea?
Immunostimulant for common cold and flu