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Antivirals / Purines / Prodrugs / Alcohols / Valganciclovir / Ganciclovir / Chemistry / Organic chemistry / Ethers


CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-257s000
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Document Date: 2010-05-27 13:41:46

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File Size: 1,03 MB

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Company

HOFFMAN-LA ROCHE INC / Age Group / /

MedicalCondition

deficiency / CMV disease / /

MedicalTreatment

kidney transplants / liver transplant / organ transplant / /

Organization

Division of Anti-Viral Products / CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER / Division of Scientific Investigations / /

Person

KEVIN M KRUDYS / Kellie S. Reynolds / SARAH M ROBERTSON / Pravin Jadhav / KELLIE S REYNOLDS / Vikram Arya / Pharmacokinetic Parameters / Kevin M. Krudys / /

Position

Clinical Pharmacology Team Leader / Pharmacometrics Team Leader / /

Product

Valcyte / Valganciclovir Tablet / Is / Description Medication / ganciclovir / Valganciclovir tablets / Concentrations Following Valganciclovir Tablets / EXECUTIVE SUMMARY Valganciclovir tablets / /

PublishedMedium

the Clinical Pharmacology Review / /

Technology

pharmacokinetics / dosing algorithm / /

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