Innovative approaches for demonstration of bioequivalence: The US FDA perspective

Therapeutic Delivery

Volumn 4, Issue 6, 2013, Pages 725-740

  Zhang, Xinyuan ^a   Zheng, Nan ^a   Lionberger, Robert A ^a   Yu, Lawrence X ^b  

^a not available   (United States)

^b WO51   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; DERMATOLOGICAL AGENT; DOXORUBICIN; EXCIPIENT; FERRIC HYDROXIDE; GASTROINTESTINAL AGENT; GENERIC DRUG; LIDOCAINE; LIPID; LIPOSOME; MACROGOL; NEW DRUG; PROGESTERONE; VANCOMYCIN;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CLASSIFICATION ALGORITHM; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG PENETRATION; DRUG SOLUBILITY; ELECTRIC POTENTIAL; ENCAPSULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERMETHOD COMPARISON; INTESTINE MUCOSA PERMEABILITY; MAXIMUM PLASMA CONCENTRATION; NARROW THERAPEUTIC INDEX; NONHUMAN; PARTICLE SIZE; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 84878725365     PISSN: 20415990     EISSN: 20416008     Source Type: Journal    
DOI: 10.4155/tde.13.41     Document Type: Review

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