ANIMAL TOXICITY REQUIREMENTS FOR CLINICAL TRIALS AND MARKETING OF A NEW DRUG ::
--------------------------------------------------------------------------------------------------------------------------------
SYSTEMIC TOXICITY STUDIES
--------------------------------------------------------------------------------------------------------------------------------
ROUTE OF DURATION OF HUMAN LONG TERM TOXICITY
ADMINISTRATION PROPOSED PHASE(S) REQUIREMENTS
HUMAN FOR WHICH
--------------------------------------------------------------------------------------------------------------------------------
Oral or Single dose or I, II, III 2sp,2wk
Parenteral or several doses
Transdermal in one day
Upto 1wk
-----------------------------------------------------------------------------------------------------------------------------
>1wk but upto I,II,III 2sp:4wk
2wk
-----------------------------------------------------------------------------------------------------------------------------
>2wk but upto I,II,III 2sp:12wk
4wk
-----------------------------------------------------------------------------------------------------------------------------
Over 1 mo I,II,III 2sp;24wk
-----------------------------------------------------------------------------------------------------------------------------
Inhalation Upto 2 wk I,II,III 2sp;1mo;(Exposure time 3h/d 5d/wk
-----------------------------------------------------------------------------------------------------------------------------
general anaesthetics
aerosols)
----------------------------------------------------------------------------------------------------------------------------
U pto 4 wk I,II,III 2sp;12wk (Exposure time 6h/d,5d/wk)
-----------------------------------------------------------------------------------------------------------------------------
> 14 wk I,II,III 2sp;24wk(Exposure time 6h/d,5d/wk)
-----------------------------------------------------------------------------------------------------------------------------
0 Comments