Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3)

AAPS Journal

Volumn 10, Issue 2, 2008, Pages 300-305

  Stavchansky, Salomon ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

BCS Class 3 drugs; Biopharmaceutics classification system; Biowaivers; Excipients

Indexed keywords

ACYLCARNITINE; CIMETIDINE; CYCLOHEXIMIDE; DETERGENT; DOCUSATE SODIUM; DODECYL SULFATE SODIUM; EXCIPIENT; FATTY ACID; FUROSEMIDE; HYDROCHLOROTHIAZIDE; MACROGOL 400; MEDIUM CHAIN ACYLGLYCEROL; OLIVE OIL; POLYSORBATE 80; PYROPHOSPHATE; RANITIDINE; SALICYLIC ACID; STEROID; SURFACTANT; THEOPHYLLINE;

ARTICLE; BIOEQUIVALENCE; DIFFUSION COEFFICIENT; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG TRANSPORT; FOOD AND DRUG ADMINISTRATION; HUMAN; IN VIVO STUDY; INTESTINE TRANSIT TIME; MEAN RESIDENCE TIME; NONHUMAN; RISK BENEFIT ANALYSIS; TIGHT JUNCTION; TISSUE CULTURE;

ANIMALS; BIOLOGICAL AVAILABILITY; BIOMEDICAL RESEARCH; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; PERMEABILITY; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 53849110857     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9030-y     Document Type: Article

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