Transcript General principle of Pharmacology

Section I
General principle of
Pharmacology
M.Y. Liu
Where can you get information about
general principle of Pharmacology?
 Text books:
 Katzung, Basic and Clinical Pharmacology
 For those who want to know more:
Goodman and Gilman’s “The
Pharmacological Basis of Therapeutics”

By email: [email protected]
Chapter 1
introduction
What is a Drug?
 Any animal, vegetable or mineral substance
used in the composition of medicines
 according to the Food, Drug, and Cosmetic
Act
 a substance recognized in an official
pharmacopoeia or formulary
 a substance intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of
disease
 a substance other than food intended to affect
the structure or function of the body
 a substance intended for use as a component of
a medicine but not a device or a component,
part, or accessory of a device
Differences between drug and
poison
 All the substances are poisons!
 There
are no distinct borderline
between them.
 Any drug will be toxic once they are
overdosed.
 toxic dose; lethal dose
What is Pharmacology?
 the study of how drugs affect a
biological system
Pharmacology
Pharmacokinetics
What the body does to drug
Pharmacodynamics
What the drug does to body
Pharmacokinetics
 Pharmacokinetics is the description of
the time course of a drug in the body,
encompassing absorption, distribution,
metabolism, and excretion.
 In simplest terms, it can be described
as what the body does to the drug.
Pharmacodynamics
 Pharmacodynamics is the study of the
biochemical and physiological effects
of drugs, in certain period.
 In brief, it can be described as what
the drug does to the body.
 Drug receptors
 Effects of drug
 Responses to drugs
 Toxicity and adverse effects of drugs
Drug development and approval
Preclinical testing
In vitro
studies
Postmarketing
surveillance
Clinical trials
Animal
testing
Long-term
toxicity studies
NDA
IND
Phase 1 – normal volunteers: safety,
pharmacokinetics
(Phase 4)
Phase 2 – selected patients:
therapeutic efficacy, dose range
Phase 3 – large populations of
selected patients: therapeutic
efficacy, safety in double blind
studies
1 to 5 years
Average years
2 to 10 years
1 year