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Tipranavir / Antiretroviral drug / Ritonavir / Saquinavir / Lopinavir / Tenofovir / Enzyme inhibitor / Zidovudine / Efavirenz / Chemistry / Organic chemistry / Protease inhibitors


Boehringer Ingelheim Pharmaceuticals, Inc. Tipranavir Capsules NDA[removed]Antiviral Drugs Advisory Committee Briefing Document, April 19, 2005 Boehringer Ingelheim Pharmaceuticals, Inc.
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Document Date: 2005-05-18 11:35:39


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File Size: 2,18 MB

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Company

AEs / PIs / Boehringer Ingelheim Pharmaceuticals Inc. / abbreviations AE / RTV co / Pharmacia / C co / Abbott Laboratories / /

Country

Guinea / Canada / /

Currency

pence / /

Event

FDA Phase / Product Recall / Product Issues / /

Facility

LABORATORY EVALUATIONS OF PIVOTAL / Laboratory Adnormalities / /

IndustryTerm

drug product / study protocol / clinical trial protocols / pharmaceutical / decisions about relevant protocol / degradation products / control / food / transport systems / trial protocols / ingelheim pharmaceuticals / bulk fill solution / treatment of HIV / chemical name / /

MedicalCondition

HIV / advanced HIV disease taking / advanced HIV disease / HIV RNA 1 / 000 / HIV epidemic / diarrhea / HIV infection / necrosis / T-cell infection / tumors / Chronic / thyroid tumors / chronic therapy demonstrating / vomiting / hepatic failure / clinical hepatitis / AIDS / infection / increased ALT / chronic Hepatitis B / cholestasis / /

MedicalTreatment

drug delivery system / Highly active antiretroviral therapy / HAART / dialysis / /

Organization

Excretion Administration / U.S. Securities and Exchange Commission / BID administration / FDA / RTV administration / TPV administration / /

Position

investigator / consultant / General / representative / investigator for the RESIST trial / /

Product

Efavirenz / zidovudine / carisoprodol / Norvir / Vitamin K / erythromycin / T-20 EAP / olanzapine / phenytoin / drug administration / Food Tipranavir capsules / abacavir / Inc. Tipranavir Capsules / RTV capsule / RESIST-1 / TPV / PI / PI-experienced / Tipranavir Capsules / CYP3A / AUC0-12h / Tipranavir / /

Technology

study protocol / Genotyping / trial protocols / chain reaction PEY Person exposure years PI Protease inhibitor PK Pharmacokinetics PPS Per protocol / clinical trial protocols / Pharmacokinetics / drug delivery system / Genotype / drug development / dialysis / /

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