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4 Preclinical E28093 Animal Study
4 Preclinical E28093 Animal Study
STUDY
Enny Rohmawaty
Department Pharmacology and Therapy
Faculty of Medicine-UNPAD
Preclinical study/preclinical trial
Preclinical trial - a laboratory test of a new drug
or a new medical device, usually done on animal
subjects, to see if the hoped-for treatment really
works and if it is safe to test on humans.
• Pre-Clinical Trials and Clinical Trials are the
processes by which scientists test drugs and
devices to see if they are SAFE and EFFECTIVE.
Experimental study
In vitro and in vivo
Animal models
Pharmacodynamic study
Toxicological study
• PHARMACODYNAMIC STUDIES
Effects / Efficacy
Mechanism of action
• TOXICOLOGICAL STUDIES
Safety
Spectrum
Pharmacodynamic study
In vitro: tissue, cell culture, blood component, etc
In vivo : whole animal
Disease model : inflammatory, dislipidemi, sepsis,
Ca/ malignancy, etc
Source of methode (literature) : Guidelines, journal
Methodology of pharmacodynamic
study
ANIMALS :
Rodent or non-rodent (may depend on desired effect)
Healthy or diseased-animal model
R eduction
• correct model
• genetic homogenity
• use healthy animal
R efinement
• caring
• treatment
• non-invasive methode
• pain, stress, distress minimization
Five Freedoms = Animal welfare
Human interactions
Enrichment Devices
for NHP
Natural Behavior of burrowing & hiding