Biopharmaceutics classification system (BCS)-based biowaiver for immediate release solid oral dosage forms of moxifloxacin hydrochloride (Moxiflox GPO) manufactured by the Government Pharmaceutical Organization (GPO)

Asian Journal of Pharmaceutical Sciences

Volumn 11, Issue 1, 2016, Pages 235-236

  Saelim, Nawaphon ^a   Suksawaeng, Khemjira ^a   Chupan, Jutamat ^a   Techatanawat, Isariya ^a  

^a Thailand Government Pharmaceutical Organization   (Thailand)

Author keywords

Biopharmaceutics classification system (BCS); Biowaiver; Moxifloxacin hydrochloride; Permeability; Solubility

Indexed keywords

MOXIFLOXACIN;

ARTICLE; BIOEQUIVALENCE; BIOPHARMACEUTICS CLASSIFICATION SYSTEM; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG MANUFACTURE; DRUG RELEASE; DRUG SOLUBILITY; TABLET;

EID: 84960121504     PISSN: 18180876     EISSN: 2221285X     Source Type: Journal    
DOI: 10.1016/j.ajps.2015.11.016     Document Type: Article

References (3)

1. U.S.Department of Health and Human Services, Food and Drug Administration Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid dosage forms based on a biopharmaceutics classification system 2000.
2. U.S.Department of Health and Human Services, Food and Drug Administration Highlights of prescribing information: AVELOX 2013, 14.
3. U.S.Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research. Briefing information for the July 26, 2011 meeting of the pharmaceutical science and clinical pharmacology advisory committee 2011.