LG 6.4 - Intro to Pharm

Question 1

Define pharmaceutics?

Answer 1

• Deals with dosage form design.

Question 2

Define drug?

Answer 2

• A substance that acts, often by interaction with regulatory molecules, to stimulate or inhibit normal physiologic/ biological processes.

Question 3

What are the two main branches of pharmacology?

Answer 3

• Pharmocodynamics

- Pharmacokinetics

Question 4

Define Pharmacodynamics?

Answer 4

• Study of the relationship between concentrations of drug and the biological effects (physiological or biochemical) over time.
• What drugs do to the body.

Question 5

Define pharmacokinetics?

Answer 5

• Study of the absorption, distribution, metabolism and excretion of drugs from the body.
• What the body does to drugs.

Question 6

What are the phases of clinical investigation for new drugs?

Answer 6

• Phase I: Establish safety (healthy volunteers)
• Phase II: Establish efficacy and dose (small # patients)
• Phase III: Verify efficacy and detect adverse affects (large # of patients)
• Phase IV: Obtain additional data following approval

Question 7

What are the phases of FDA approval?

Answer 7

1) Drug companies submit data for NEW DRUG APPLICATION (NDA).
2) FDA approves drug for indications asked for by company based on efficacy and safety data in the NDA.
3) Once marketed, prescribers, however, can use drugs for non-FDA-approved or “off-label” indications.
4) Drugs with an increased safety risk, high-cost, etc. may have prescribing restrictions enacted by the FDA, hospital or payer.

Question 8

Prescription vs. OTC drugs?

Answer 8

• Prescription: regulated by federal government can only be obtained by a prescription from a health care provider.
• OTC: on shelf drugs, do not need prescriptions.

Question 9

Trade name, generic name, and chemical name?

Answer 9

• Trade name: easy to remember.
• Generic name: shortened version of chemical name usually.
• Chemical name: super long naming chemicals.