5010 Pathology- Pharmacology Flashcards
Steps for Drug Access/ FDA approval
a. pre-clinical trials
b. clinical trials (4 stages)
c. applictaion to FDA
d. approval for given use
e. approval for marketing- alternative uses.
Controlled Drug Access:
Schedules I-V
I. NEVER prescribe (heroin)
II. Prescribed but highly controlled (narcotics)
III & IV. Prescriptions
V. Over-the-counter
Pharmacokinetics Overview
a. Administration- dose
b. Absorption
c. Bioavailability- (conc. in blood & other tissues)
d. Clearance (metabolism- liver, excretion- urine)
Drug Administration (2 types w/ subcategories)
a. Enteral
(Oral, Sublingual, Rectal)
b. Parental
(Topical, Injection, Inhalation)
Bioavailability: Volume of Distribution
(Amount of Drug Administered)
= ———————————————
(Concentration of drug in plasma)
Vd and TWB
Volume Distribution and Total Body Water
Meanings
Vd = TBA Equal Distribution
Vd > TBA Less Plasma Concentration
Vd
Factors involved in bioavailability
i. blood flow
ii. tissue permeability
iii. plasma protein binding
iv. tissue binding
Elimination Methods
- Biotransformation/Metabolism
- Excretion
- Volatilization