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Non-nucleoside reverse transcriptase inhibitors / Amines / Drug rehabilitation / Lactams / Nevirapine / Methadone / Chemistry / Organic chemistry / Cyclopropanes


CLINICAL PHARMACOLOGY REVIEW NDA: [removed]SE5 027 &[removed]SE5 017 Submission Date(s): December 20, 2007 Brand Name
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Company

Five Pediatric AIDS Clinical Trials Group / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

Treatment of HIV / body surface area algorithm / body weight algorithm / /

MedicalCondition

HIV infection / hepatic fibrosis / patient’s liver disease / HIV / disease / chronic treatment / chronic liver disease / HIV RNA / moderate-to-severe hepatic dysfunction / AIDS / infection / organ dysfunction / MS / rash / hepatic cirrhosis / hepatic insufficiency / fibrosis / /

Organization

OCP Division Division of Clinical Pharmacology / office of Clinical Pharmacology / /

Person

Yuanchao (Derek) Zhang / Nevirapine Reviewer Yuanchao / Kellie S. Reynolds / /

Position

Team Leader / E. General / Executive / central pathologist / General / Based Review A. General / /

Product

Nevirapine / VIRAMUNE / Oral suspension / SE5 / NVP / HIV-1 / /

Technology

pharmacokinetics / BSA algorithm / body weight algorithm / body surface area algorithm / pharmacodynamics / approved body weight algorithm / using the BSA algorithm / /

SocialTag