PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms

Journal of Pharmaceutical Sciences

Volumn 96, Issue 6, 2007, Pages 1451-1467

  Snorek, Sharon M ^c   Bauer, John F ^a   Chidambaram, Nallaperumal ^d   Doub, William H ^d   Duffy, Eric P ^d   Etzler, Frank M ^b   Kelly, Richard N ^f   Lane, Justin J ^j   Mueller, Ronald L ^e   Prasanna, Hullahalli R ^d   Pujara, Chetan P ^a   Reif, Van D ^g   Scarlett, Brian ⁱ   Stowell, Joseph G ^h   Toma, Pascal H ^e  

^a ABBOTT LABORATORIES   (United States)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^c ELI LILLY AND COMPANY   (United States)

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

^e GLAXOSMITHKLINE   (United States)

^f JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^g MERCK RESEARCH LABORATORIES   (United States)

^h Chao Center   (United States)

ⁱ UNIVERSITY OF FLORIDA   (United States)

^j UNITED STATES PHARMACOPEIA   (United States)

more..

Author keywords

Analysis; Image analysis; Light scattering; Microscopy; Morphology; Particle size

Indexed keywords

ACCURACY; ANALYTIC METHOD; DISPERSION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; IMAGE ANALYSIS; LASER DIFFRACTION; MICROSCOPY; MORPHOLOGY; ORAL DRUG ADMINISTRATION; PARTICLE SIZE; REPRODUCIBILITY; SCANNING ELECTRON MICROSCOPY; SENSITIVITY AND SPECIFICITY; SHORT SURVEY; VALIDATION PROCESS;

EID: 34250712279     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20822     Document Type: Article

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