Bioavailability and bioequivalence in drug development

Wiley Interdisciplinary Reviews: Computational Statistics

Volumn 6, Issue 4, 2014, Pages 304-312

  Chow, Shein Chung ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Drug interchangeability; Fundamental bioequivalence assumption; Highly variable drugs; Scaled average bioequivalence (SABE) criterion

Indexed keywords

BIOCHEMISTRY; COMPETITION;

DRUG INTERCHANGEABILITY; FUNDAMENTAL BIOEQUIVALENCE ASSUMPTION; HIGHLY VARIABLE DRUGS; REGULATORY REQUIREMENTS; RELATIVE BIOAVAILABILITY; SAMPLE SIZE DETERMINATION; SCALED AVERAGE BIOEQUIVALENCE (SABE) CRITERION; UNITED STATES FOOD AND DRUG ADMINISTRATIONS;

DRUG PRODUCTS;

EID: 84903276991     PISSN: 19395108     EISSN: 19390068     Source Type: Journal    
DOI: 10.1002/wics.1310     Document Type: Article

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