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NOTES BY: BALAGTAS & LOPEZ | EDITED BY: REYES, N. & RODRIGUEZ BSN 2-1 | PAGE 1
FUNDAMENTAL CONCEPTS
WEEK 2 OCT. 13, 2020
OF PHARMACOLOGY
a. Preclinical Trials - tested on laboratory d. Category D: proven risk to human fetus; risk
animals to identify presumed effects on vs. benefit must be determined; could be
living tissue and to evaluate adverse effects used in life-threatening conditions
- tests the possible useful effects, e. Category X: proven risk to human fetus; risk
toxicity, & pharmacokinetics outweighs the benefit; drug should be
b. Phase I Studies - subjects: healthy human avoided during pregnancy
volunteers (usually men) Drug Schedules (Controlled Substances) –
- tests metabolism, biologic effects, ● CI – high potential of being abused, no
adverse effects, toxicity, & benefits (e.g. morphine and
pharmacokinetics methamphetamine)
c. Phase II Studies - subjects: patients ● CII – Codeine - special prescription, yellow
- tests therapeutic utility and dosage slip is given by the physician)
range ● CIII, CIV, CV – safe
d. Phase III Studies - subjects: patients (large
scale); monitors for adverse or unforeseen
effects
- tests safety and effectiveness
e. Phase IV - Post marketing Surveillance;
drug is released for general use, permitting
observation of its effects in a large
population
Drug Names
● Common (name by which a certain drug is
known as)
● Generic (name derived from its active
ingredient)
● Chemical (Chemical Formula)
● Brand (trade name given by the
manufacturer)
NOTES BY: BALAGTAS & LOPEZ | EDITED BY: REYES, N. & RODRIGUEZ BSN 2-1 | PAGE 2