Changes

Toxicology

1,228 bytes added, 17:11, 21 November 2009
/* Sample Example */
==Sample Example==
 
Cyclopropavir (CPV,ZSM-I-62,MBX400)has been shown to be potent against beta-and gamma-herpes viruses
Here is the study conducted to test the toxicology and pharmacokinetics of this active on rat
 
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|align = "center" bgcolor = "#339966" colspan = "7"|'''Summary of Primary Pharmacokinetic, Toxicokineticand Toxicology Studies'''
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===Summary===
'''Pharmacokinetic data (plasma)'''
 
*In the single dose rat PK study, exposure was less than dose proportional
*Orally bioavailable
*Rat 10 mg/kg oral Cmax: 739 ng/mL(2.8 μM)
*Rat 10 mg/kg intravenous Cmax: 14,500 ng/mL(55 μM)
 
'''Toxicokineticdata (plasma)'''
 
*Exposure generally increased with increasing doses
*Plasma concentrations were generally higher after the first dose than after the fourteenth daily dose
*Cmaxvalues in the rat were 1175 and 977 ng/mLin females (4.5 and 3.9 μM) and 1763 and 1026 ng/mLin males (6.7 and 3.7 μM) at 100 mg/kg after 1 day and 14 days of dosing, respectively
 
'''Toxicology studies'''
*Maximum tolerated dose 100 mg/kg (oral; dog) and 300 mg/kg (oral; rat)
*Dose-limiting toxicity at 300 mg/kg (orally; dog)
*Few toxic signs in expected therapeutic range
*Toxicology studies established target organ(s)which are similar to other drugs in class: kidney and possibly hematologic system
*Toxicology studies paired with pharmacology data show acceptable margin of safety
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