Intro Flashcards
What is the main goal of in vitro studies of drug development?
Discovering a “lead compound” from biological and/or chemical products. (takes an average of 2 years)
What are the three factors typically tested during animal testing?
1) Efficacy 2) Selectivity 3) Mechanism
Which phases take place during “Clinical Testing” and what question does each hope to answer?
Phase 1- “Is it safe?”… pharmacokinetics
Phase 2- “Does it work in patients?”
Phase 3- “Does it work with genetic variations, double blind?”
Takes an average 4 years.
When is a drug considered an IND and what does that stand for?
Investigational New Drug- after approved animal testing and at the start of clinical testing; usually when the drug is patented
What is happening during phase 4?
Postmarketing surveillance
What type of research is considered the “Valley of Death” when it comes to development funding?
Translational Research: a mix of government & private funding
Pure Food and Drug Act (1906)
After release of “The Jungle”: Insures purity and proper labeling
Federal Food, Drug and Cosmetic Act (1938)
Requires toxicity studies for safety; enforced by FDA
Kefauver-Harris Amendments (1962)
Requires proof of efficacy, established guidelines for reporting adverse effects, clinical testing & advertising, and established FDA authority over manufacturing
FDA Modernization Act (1997)
- Expedited reviews for drugs for serious diseases; permits marketing even before Phase 2 and 3 studies completed
- Exp. AIDS drug, Indinivar, approved in 42 days! WOWZA
What is the difference between a dietary supplement and a drug?
Dietary supplements do not go through the same extensive evaluations. They can’t say that they are good for any particular disease state.
CAN NOT PATENT HERBALS IN THE US (not profitable)
How does FDA regulate herbals, supplements, minerals, and vitamins?
Only regulates sanitary production conditions and good laboratory practices. There is no requirement to prove efficacy or safety!!!!!! (yikes.)
Dietary Supplement and Non-Rx Drug Consumer Protection Act (2006)
Requires manufacturer to report serious adverse events
Indications for St John’s Wort (Hypericum Perforatum)
Mild/moderate depression
Pharmacology SJW
Perennial weed containing hyperforin and hypericin
Toxicities/Side effects SJW
Photosensitivity(?); GI complaints
Potential interactions SJW
- Reduced efficacy of some drugs- including ORAL CONTRACEPTIVES
- Induces CYP3A4, CYP2C9 (drug metabolizing enzymes) and P-gp (can pump drugs out of cells)
Indications for Echinacea
Common cold and flu (some evidence of decreasing symptoms/duration of URI)
Pharmacology: Echinacea
Contains polysaccharides, chicoric acid, alkamides…
Toxicity/Side Effects: Echinacea
Minimal: GI upset and headache
Contraindications: Echinacea
- NOT for CHILDREN
- Shouldn’t be taken for longer than 10 days
- Should be avoided in patients taking immunosuppressants, or with immunodeficiency, or autoimmune diseases
Indications: Ginkgo (Ginkgo biloba) (the worst smelling trees in the world)
- Cardiovascular Disease (UNPROVEN)
- Preventative for cognitive impairment or dementia (UNPROVEN)
Pharmacology: Ginkgo
- Flavone glycosides; terpenoids
- Antioxidants; antagonize platelet activating factor; increase NO release
Toxicity/Side effects: Ginkgo
Headache, GI upset, “some bleeding”
