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Pharmacology/Toxicology information to submit an IND for an anticancer drug

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Pharmacology/Toxicology information to submit an IND for an anticancer drug
[object Object]
Disciplines involved in the review process of applications for oncology drug products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmacology/ Toxicology Nonclinical Development ,[object Object],[object Object],[object Object],[object Object]
Pharmacology Studies ,[object Object],[object Object]
Toxicology: The search for the unexpected
Toxicology Studies ,[object Object],[object Object],[object Object],[object Object]
Toxicology Studies (cont’d) ,[object Object],[object Object],[object Object],[object Object]
Toxicology Studies (cont’d) ,[object Object]
Common Types of Toxicity Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmacokinetic (ADME) Studies ,[object Object],[object Object],[object Object],[object Object]
Nonclinical Information (Item 8 of the IND) ,[object Object],[object Object]
Interpretation of the data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],http://www.fda.gov/cder/cancer/docs/doseflow.pdf
Good Laboratory Practices (GLP) 21CFR 58 ,[object Object]
Good Laboratory Practices (GLP) http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr58_00.html
Plan in Advance Estimated Costs of Toxicology Studies Anticancer Drug Development Guide; BA Teicher and PA Andrews
Example of Poor Planning! Acknowledge that planning is a dynamic process
User Fee ,[object Object],[object Object],[object Object],[object Object],[object Object]
Resources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
Resources (cont’d) ,[object Object]
 
Resources (cont’d) ,[object Object],[object Object]
 
Resources (cont’d) ,[object Object]
 

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Khaleelullayudae dhanya jeevitham maatrukayaakkunnathu
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Lailathul qadar
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Prarthana sweeekarikkaathirikkaanulla patthu kaaranangal
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Islamilae abhivaadyam
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Visarjana maryaathakal
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വുളുവിന്റെ രൂപം
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Yaatraa maryaathakal
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Urakkam sharddikkenda sunnathukal
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Pravachakanmaariloodae
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Namaskarikkunnavar santhoshikkuka
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Namaskaara sheshamulla dikrukal
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Hope..
Hope..Hope..
Hope..
 

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