Biowaiver monographs for immediate release solid oral dosage forms: Quinidine sulfate

Journal of Pharmaceutical Sciences

Volumn 98, Issue 7, 2009, Pages 2238-2251

  Grube, S ^a   Langguth, P ^a   Junginger, H E ^b   Kopp, S ^c   Midha, K K ^d   Shah, V P ^e   Stavchansky, S ^f   Dressman, J B ^g   Barends, D M ^h  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b NARESUAN UNIVERSITY   (Thailand)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

^d UNIVERSITY OF SASKATCHEWAN   (Canada)

^e International Pharmaceutical Federation FIP   (Netherlands)

^f UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^g GOETHE UNIVERSITY   (Germany)

^h NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Absorption; Biopharmaceutics Classification System (BCS); Dissolution; Permeability; Quinidine sulfate; Regulatory science; Solubility

Indexed keywords

BASIC BUTYLATED METHACRYLATE COPOLYMER; CALCIUM CARBONATE; CARNAUBA WAX; CELLULOSE; EXCIPIENT; FUROSEMIDE; HYDROCHLOROTHIAZIDE; LACTOSE; MACROGOL; MAGNESIUM STEARATE; METHACRYLIC ACID DERIVATIVE; METOPROLOL; NEW DRUG; POLYSORBATE 80; POTATO STARCH; POVIDONE; PROPRANOLOL; QUINIDINE SULFATE; SILICON DIOXIDE; STARCH; STARCH GLYCOLATE SODIUM; STEARATE CALCIUM; STEARIC ACID DERIVATIVE; SUCROSE; TALC; UNCLASSIFIED DRUG; WAX;

BIOEQUIVALENCE; DEATH; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG CLASSIFICATION; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG EXCRETION; DRUG PENETRATION; DRUG PROTEIN BINDING; DRUG RELEASE; DRUG SAFETY; DRUG SOLUBILITY; DRUG STABILITY; DRUG STRUCTURE; EXCIPIENT COMPATIBILITY; FIRST PASS EFFECT; FOOD DRUG INTERACTION; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART VENTRICLE ARRHYTHMIA; HUMAN; IN VITRO STUDY; MALARIA; NONHUMAN; NOTE; PARTITION COEFFICIENT; PH; PKA; SIDE EFFECT; TABLET; TREATMENT INDICATION;

EID: 67650178817     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21606     Document Type: Note

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