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In vivo PK
Early stage PK data for NCE evaluation:
- Rats and mice
- Multiple routes of administration (IV, PO, IP, IM, SC, IN)
- Cassette dosing studies
- Determination of fundamental PK parameters (Tmax, Cmax, AUC, clearance, oral bioavailability, volume of distribution, etc.)
Acute toxicity studies in rodents and rabbits:
- Single dose toxicity
- Multiple dose toxicity
- Determination of Maximum Tolerable Dose
Animal Facility
- Non - GLP
- Sterile dress change room
- Animal rooms with controlled temperature and humidity
- Quarantine rooms
- Autoclave & Wash rooms
- Surgery room
- Approved by CPCSEA, Government of India
- Monitored by IAEC
- Laboratory Animals
- Rats (Wistar, Sprague Dawley)
- Mouse (Swiss albino, Balb/C, C57 etc)
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