Establishment of in vitro-in vivo equivalence of highly variable drugs - A generic product development perspective

Pharmaceutical Development and Technology

Volumn 19, Issue 4, 2014, Pages 401-410

  Pathak, Shriram M ^a   Aggarwal, Deepika ^a   Venkateswarlu, V ^a  

^a DR REDDY'S LABORATORIES LTD   (India)

Author keywords

Bioequivalence; Dissolution; FaSSGF; SABE; Telmisartan; Variability

Indexed keywords

GENERIC DRUG; TELMISARTAN;

ABSENCE OF SIDE EFFECTS; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; DRUG SOLUBILITY; HUMAN; IN VITRO STUDY; IN VIVO STUDY; NORMAL HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIMULATION; TABLET DISINTEGRATION;

BENZIMIDAZOLES; BENZOATES; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; DRUGS, GENERIC; HUMANS; SOLUBILITY; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 84898755210     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2013.788513     Document Type: Article

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