Biowaiver monographs for immediate release solid oral dosage forms: Levofloxacin

Journal of Pharmaceutical Sciences

Volumn 100, Issue 5, 2011, Pages 1628-1636

  Koeppe, Marcelle O ^a   Cristofoletti, Rodrigo ^a   Fernandes, Eduardo F ^a   Storpirtis, Silvia ^b   Junginger, Hans E ^c   Kopp, Sabine ^d   Midha, Kamal K ^e   Shah, Vinod P ^f   Stavchansky, Salomon ^g   Dressman, Jennifer B ^h   Barends, Dirk M ⁱ  

^a Brazilian Health Surveillance Agency (Anvisa)   (Brazil)

^b UNIVERSITY OF SÃO PAULO   (Brazil)

^c NARESUAN UNIVERSITY   (Thailand)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^e UNIVERSITY OF SASKATCHEWAN   (Canada)

^f International Pharmaceutical Federation FIP   (Netherlands)

^g UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^h GOETHE UNIVERSITY   (Germany)

ⁱ NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Absorption; Biopharmaceutics Classification System (BCS); Levofloxacin; Permeability; Regulatory science; Solubility

Indexed keywords

EXCIPIENT; GENERIC DRUG; LEVOFLOXACIN; POLYSORBATE;

ARTICLE; BIOEQUIVALENCE; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG ELIMINATION; DRUG METABOLISM; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STRUCTURE; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HUMAN EXPERIMENT; INSOMNIA; LD 50; LIVER DISEASE; MALE; MOUSE; NAUSEA; NONHUMAN; PARTITION COEFFICIENT; PH; PKA; RAT; SIDE EFFECT;

EID: 79952248623     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22413     Document Type: Note

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