Determination of bioequivalence for drugs with narrow therapeutic index: Reduction of the regulatory burden

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 16, Issue 5, 2013, Pages 676-682

  Endrenyi, Laszlo ^a   Tothfalusi, Laszlo ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

TACROLIMUS; WARFARIN;

ARTICLE; BIOEQUIVALENCE; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; LIMIT OF QUANTITATION; NARROW THERAPEUTIC INDEX; PHARMACODYNAMICS; PHARMACOLOGICAL PARAMETERS; PROBABILITY; REFERENCE VALUE; SCALED AVERAGE BIOEQUIVALENCE;

ANTICOAGULANTS; HUMANS; LEGISLATION, DRUG; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WARFARIN;

EID: 84888397284     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/j31k51     Document Type: Article

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