Basics

Question 1

Clinical trial phases

Answer 1

Phase 1: preclinical investigation; drug testing on small group (~20-80)

Phase 2: clinical investigation; drug testing on slightly larger group (~100)
Phase 3: NDA review (the cuck stage); drug testing on large group (~1k-3k)

Phase 4: postmarketing study

Question 2

Common causes for phase 3 failure

Answer 2

Efficacy, safety (and a little bit of commerical)

Question 3

Drug classes

Answer 3

Abuse:
I to V, I being most abuse-able and V being not abuse-able

Pregnancy:
A to D, then X, with A being the safest for pregnant women and X being the highest risk to both the woman and fetus

Question 4

Drug administration

Answer 4

Enteral, NG, Sublingual, buccal, topical, transdermal, nasal, otic (ear), rectal, parenteral (IV)

Question 5

drug administration route

Answer 5

1. absorption
2. distribution
3. first pass metabolism (liver)
4. metabolism
5. excretion

Question 6

First Pass Metabolism

Answer 6

phenomenon of drug metabolism at a specific location (liver’s hepatic portal circulation) in the body which leads to a reduction in the concentration of the active drug before it reaches the site of action or systemic circulation.

Question 7

Potency and Efficacy

Answer 7

Potency: drug’s strength at a certain conc.
Efficacy: drug’s ability to produce a more intense response as concentration increases
TLDR:
- potency = dose
- efficacy = % of drug response

Priority lies in efficacy > potency (less is more)

Onset: how long for drug to exert therapeutic effect
Duration: how long the drug lasts

Question 8

Critical threshold

Answer 8

Minimum effective conc.: minimum amt of drugs needed for effect
Maximum safe conc.: maximum amt of drugs before you OD
Maximal effect: greatest response the drug can produce

Question 9

Pharmacology includes

Answer 9

1. drug administration
2. drug disintegration (pharmaceutics)
3. drug ADME (pharmacokinetics)
4. drug/receptor interaction (pharmacodynamics)
5. drug effect/ response (pharmacotherapeutics)