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TOXICOLOGY STUDIES
(NON-CLINICAL STUDIES)
SWATI SARIN
WHY STUDY TOXICOLOGY???
Patients Patients
Healthy subjects Patients
None Large scale Large scale
Safety and Small scale post-marketing
multicentre
tolerability efficacy studies studies studies
Genetic toxicity
Genetic toxicity
(in vivo)
(in vitro)
Repeat dose Chronic (long term) toxicity testing
Non-clinical
Pharmacokinetic profile
Hypersensitivity studies
Genotoxicity studies
Carcinogenicity studies
A. SYSTEMIC TOXICOLOGY STUDIES
Preliminary Definitive
METHOD
Physiological
Biochemical
Microscopic observations
B. REPRODUCTIVE TOXICOLOGY STUDIES
a) MALE FERTILITY
METHOD
One rodent species(rat)
15
C. LOCAL TOXICITY STUDIES
Study design:
2 species along with control used
Dose dependent on dose escalating studies
3 dose levels
TYPES OF LOCAL TOXICITY STUDIES
Dermal toxicity studies Rats & Rabbit
Local signs (erythema, oedema),
histological examination
Life-time Bioassays