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PHARMACOEPIDEMIOLOGY

(Block of CHEM I)
Eman Sutrisna
Departement of Pharmacology and Therapy
Medical School Unsoed
LEARNING OBJECTIVES
Student able to explain :
Definition dan lingkup
farmakoepidemiologi
Development of pharmacoepidemiology
Drug regulation and evaluation
Application of pharmacoepidemiological
research design to enhance the
pharmacotherapeutic services quality

LEARNING TOPICS
Pharmcoepidemiology
Drug regulation and evaluation
Post marketing clinical trial

PHARMACOEPIDEMIOLOGY
The application of epidemiologic
methods, knowledge and reasoning to
subject of clinical pharmacology.
Focusing on the study of the use of
the effects of drugs in large numbers
of people


A subdiscipline of clinical pharmacology
PHARMACOEPIDEMIOLOGY approaches
Single case report to the
observational or non-experimental
population based approach with
several years follow-up.
Large scale randomized clinical
trial
The Field OF PHARMACOEPIDEMIOLOGY
Causality and incidence of adverse drug
reaction
Effectiveness of new drug
Patterns of and variations in prescribing in
particular health care facility or area
Strategies to improve prescribing.
Evaluation of the appropriateness of drug
use
Development of guidelines for treatment
National drug policy
Health cost
DRUG REGULATION AND EVALUATION
Important in drug development
(Investigation New Drug IND) I
ensure human safety
Very costly
To cover the time period from lab to
the retail pharmacy (>12 years)
There are 2 steps :
Preclinical trial
Clinical trial
PRE CLINICAL TRIAL
Animal study
Laboratory based
To evaluate :
Active compound
Performing pharmacological
Toxicology
Safety testing
CLINICAL TRIAL
Human study
Phase I
Small number of subject (30)
Healthy volunteer
By clinical pharmacologist
Determine metabolism of the drug in
human
A safe dosage
Extremly toxic effect in human

Phase II
Patient who have a target disease
100-200 subject
By clinical pharmacologist
Determine pharmacokinetic of the drug
Additional toxic effect
Preliminary information on the efficacy
Dosage regiment
Phase III
Large number of patient (several
hundred-thousands)
By clinical researcher
To verifies phase I and II
To make sure and proves that the
drug is more effective than
previously available drugs

Phase IV
Post marketing surveillance.
Conducted once the drug is
approved
To gather information a long term
outcome
Long term adverse reaction
Neoplastic effect
Terratogenic effect
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