Highly variable drugs: Observations from bioequivalence data submitted to the FDA for new generic drug applications

AAPS Journal

Volumn 10, Issue 1, 2008, Pages 148-156

  Davit, Barbara M ^a   Conner, Dale P ^a   Fabian Fritsch, Beth ^a   Haidar, Sam H ^a   Jiang, Xiaojian ^a   Patel, Devvrat T ^a   Seo, Paul R H ^a   Suh, Keri ^a   Thompson, Christina L ^a   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Bioequivalence; Generic drugs; Highly variable drugs; Presystemic drug metabolism; Variable drug product dissolution

Indexed keywords

ALPHA ADRENERGIC RECEPTOR STIMULATING AGENT; ANDROGEN; ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ANTIARRHYTHMIC AGENT; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; ANTINEOPLASTIC AGENT; ANTITHROMBOCYTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DOPAMINE RECEPTOR STIMULATING AGENT; GENERIC DRUG; HISTAMINE H1 RECEPTOR ANTAGONIST; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; MUSCLE RELAXANT AGENT; PEPTIDE HORMONE; PROSTAGLANDIN E1 DERIVATIVE; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SEROTONIN 1A AGONIST; SEROTONIN 1B AGONIST; SEROTONIN 1D AGONIST; SPASMOLYTIC AGENT; VITAMIN D DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG SOLUBILITY; FIRST PASS EFFECT; FOOD AND DRUG ADMINISTRATION; HUMAN; MAXIMUM PLASMA CONCENTRATION; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 51249120275     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9015-x     Document Type: Article

References (13)

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