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Toxicology

9,633 bytes added, 17:07, 21 November 2009
/* Sample Example */
|align = "center"| 15 <nowiki>+</nowiki> 9 TK
|align = "center"|&nbsp;
 
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{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#339966" colspan = "11"|'''Single-Dose Pharmacokinetic and ToxicokineticParameters'''
 
|-
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Species (Strain) '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Study '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Route '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Dose (mg/kg) '''
|align = "center" bgcolor = "#33CCCC" colspan = "2"|''' No. of Animals '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' AUC0-∞(ng∙hr/mL) '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' t1/2(hr) '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Cmax(ng/mL) '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' Tmax(hr) '''
|align = "center" bgcolor = "#33CCCC" rowspan = "2"|''' F (%) '''
 
|-
|align = "center" bgcolor = "#33CCCC"|'''M'''
|align = "center" bgcolor = "#33CCCC"|'''F'''
 
|-
|align = "center"| Rat (Sprague Dawley)
|align = "center"| Single Dose PK
|align = "center"| i.v.
|align = "center"| 10
|align = "center"| 9
|align = "center"| -
|align = "center"| 10735
|align = "center"| 2.34
|align = "center"| 14500
|align = "center"| 0.083
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| Oral
|align = "center"| 1
|align = "center"| 9
|align = "center"| -
|align = "center"| 494
|align = "center"| 1.09
|align = "center"| 262
|align = "center"| 0.5
|align = "center"| 46.0
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 5
|align = "center"| 9
|align = "center"| -
|align = "center"| 1638
|align = "center"| 1.23
|align = "center"| 590
|align = "center"| 0.5
|align = "center"| 30.5
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 10
|align = "center"| 9
|align = "center"| -
|align = "center"| 2435
|align = "center"| 1.12
|align = "center"| 739
|align = "center"| 0.5
|align = "center"| 22.7
 
|-
|align = "center"|&nbsp;
|align = "center"| 14-Day Toxicity/TK
|align = "center"| Oral
|align = "center"| 10
|align = "center"| 9
|align = "center"| -
|align = "center"| 2413
|align = "center"| 1.51
|align = "center"| 612
|align = "center"| 1.00
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| -
|align = "center"| 9
|align = "center"| 1843
|align = "center"| 3.74
|align = "center"| 682
|align = "center"| 0.50
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 50
|align = "center"| 9
|align = "center"| -
|align = "center"| 7671a
|align = "center"| ND
|align = "center"| 1517
|align = "center"| 2.00
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| -
|align = "center"| 9
|align = "center"| 7055
|align = "center"| 3.08
|align = "center"| 1131
|align = "center"| 2.00
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 100
|align = "center"| 9
|align = "center"| -
|align = "center"| 11749
|align = "center"| 3.30
|align = "center"| 1763
|align = "center"| 1.00
|align = "center"| -
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| -
|align = "center"| 9
|align = "center"| 9129a
|align = "center"| ND
|align = "center"| 1175
|align = "center"| 4.00
|align = "center"| -
 
|}
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#339966" colspan = "14"|'''Selected Hematology Data from Rat Single-Dose -Escalating Toxicology Studies'''
 
|-
|bgcolor = "#33CCCC"|''' Species (Strain) '''
|bgcolor = "#33CCCC"|''' Sex '''
|bgcolor = "#33CCCC"|''' Dose (mg/kg)a '''
|bgcolor = "#33CCCC"|''' Red Blood Cell Count(1x106/μL) '''
|bgcolor = "#33CCCC"|''' Hemoglobin (g/dL) '''
|bgcolor = "#33CCCC"|''' Hematocrit(%) '''
|bgcolor = "#33CCCC"|''' Mean Corpuscular Volume (femtoliter) '''
|bgcolor = "#33CCCC"|''' Mean Corpuscular Hemoglobin (pg) '''
|bgcolor = "#33CCCC"|''' Mean Corpuscular Hemoglobin Conc. (g/dL) '''
|bgcolor = "#33CCCC"|''' Reticulocytes(1x103/μL) '''
|bgcolor = "#33CCCC"|''' Platelets (1x103/μL) '''
|bgcolor = "#33CCCC"|''' White Blood Cell Count (1x103/μL) '''
|bgcolor = "#33CCCC"|''' Neutrophils (1x103/μL) '''
|bgcolor = "#33CCCC"|''' Lymphocytes(1x103/μL) '''
 
|-
| Rat (Sprague Dawley)b
| M
| 0
| 6.94±0.221
| 14.3 ±0.48
| 44.5 ±1.89
| 64.1 ±1.52
| 20.6 ±0.36
| 32.2 ±0.33
| 544.5 ±30.82
| 1448 ±288.8
| 7.15 ±0.885
| 0.71±0.214
| 6.19 ±0.984
 
|-
|&nbsp;
|&nbsp;
| 300
| 7.27 ±0.537
| 14.7 ±0.70
| 48.0 ±3.02
| 63.4 ±2.37
| 20.2 ±0.81
| 31.9 ±0.80
| 503.3 ±67.80
| 1228 ±201.6
| 6.42 ±1.189
| 0.79 ±0.338
| 5.32 ±1.153
 
|-
|&nbsp;
| F
| 0
| 7.29 ±0.150
| 14.8 ±0.23
| 44.7 ±0.58
| 61.2 ±0.58
| 20.3 ±0.25
| 33.2 ±0.24
| 353.2 ±10.97
| 1328 ±104.2
| 6.24 ±1.442
| 0.75 ±0.233
| 5.15 ±1.443
 
|-
|&nbsp;
|&nbsp;
| 300
| 7.55 ±0.185
| 15.2 ±0.28
| 45.6 ±1.11
| 60.4 ±4.41
| 20.1 ±0.52
| 33.3 ±0.38
| 333.0 ±52.44
| 1245 ±166.6
| 7.66 ±1.944
| 0.63 ±0.374
| 6.70 ±1.693
 
|}
 
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#339966" colspan = "8"|'''Safety Pharmacology Studies'''
 
|-
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| Species (Strain)
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| Study Type
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| Route
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| Dose (mg/kg)
|align = "center" bgcolor = "#33CCCC" colspan = "2"| No. of Animals
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| GLP?
|align = "center" bgcolor = "#33CCCC" rowspan = "2"| Results
 
|-
|align = "center" bgcolor = "#33CCCC"| M
|align = "center" bgcolor = "#33CCCC"| F
 
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|align = "center"| Rat (Sprague Dawley)
|align = "center"| Central Nervous System
|align = "center"| Oral
|align = "center"| 0
|align = "center"| 6
|align = "center"| 6
|align = "center"| Yes
|align = "center"| Cyclopropavirhad no effect on clinical signs, body weight or Irwintest results
 
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|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|10
|align = "center"| 6
|align = "center"| 6
|align = "center"|&nbsp;
|align = "center"|&nbsp;
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 50
|align = "center"| 6
|align = "center"| 6
|align = "center"|&nbsp;
|align = "center"|&nbsp;
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 100
|align = "center"| 6
|align = "center"| 6
|align = "center"|&nbsp;
|align = "center"|&nbsp;
 
|}
 
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#339966" colspan = "13"|'''Selected Clinical Chemistry Data from Rat Single-Dose Escalating Toxicology Studies'''
 
|-
|align = "center" bgcolor = "#33CCCC"|''' Species (Strain) '''
|align = "center" bgcolor = "#33CCCC"|''' Sex '''
|align = "center" bgcolor = "#33CCCC"|''' Dose (mg/kg) '''
|align = "center" bgcolor = "#33CCCC"|''' Urea Nitrogen (mg/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Creatinine(mg/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Total Protein (g/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Albumin (g/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Globulin (g/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Albumin Globulin Ratio '''
|align = "center" bgcolor = "#33CCCC"|''' Calcium (mg/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Phosphorus (mg/dL) '''
|align = "center" bgcolor = "#33CCCC"|''' Sodium (mmol/L) '''
|align = "center" bgcolor = "#33CCCC"|''' Potassium(mmol/L) '''
 
|-
|align = "center"| Rat (Sprague Dawley)a,b
|align = "center"| M
|align = "center"| 0
|align = "center"| 14 ±1.1
|align = "center"| 0.5±0.00
|align = "center"| 5.7 ±0.24
|align = "center"| 4.0 ±0.12
|align = "center"| 1.7 ±0.05
|align = "center"| 2.4 ±0.09
|align = "center"| 10.8 ±0.11
|align = "center"| 11.0 ±0.51
|align = "center"| 147 ±1.3
|align = "center"| 5.8 ±0.31
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 300
|align = "center"| 13 ±1.3
|align = "center"| 0.5 ±0.00
|align = "center"| 5.8 ±0.43
|align = "center"| 4.1 ±0.12
|align = "center"| 1.7 ±0.11
|align = "center"| 2.4 ±0.13
|align = "center"| 10.9 ±0.28
|align = "center"| 10.6 ±0.27
|align = "center"| 148 ±1.6
|align = "center"| 5.8 ±0.37
 
|-
|align = "center"|&nbsp;
|align = "center"| F
|align = "center"| 0
|align = "center"| 15 ±1.3
|align = "center"| 0.6 ±0.05
|align = "center"| 6.0 ±0.18
|align = "center"| 4.4 ±0.05
|align = "center"| 1.7 ±0.18
|align = "center"| 2.7 ±0.31
|align = "center"| 11.1 ±0.30
|align = "center"| 9.5 ±0.40
|align = "center"| 147 ±1.0
|align = "center"| 5.4 ±0.4
 
|-
|align = "center"|&nbsp;
|align = "center"|&nbsp;
|align = "center"| 300
|align = "center"| 15 ±2.3
|align = "center"| 0.5 ±0.04
|align = "center"| 6.1 ±0.18
|align = "center"| 4.6 ±0.08
|align = "center"| 1.6 ±0.17
|align = "center"| 3.0 ±0.35
|align = "center"| 11.3 ±0.11
|align = "center"| 9.7 ±0.72
|align = "center"| 147 ±2.3
|align = "center"| 5.5 ±0.5
|}
Lakshmikantg
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