The U.S. draft guidance regarding population and individual bioequivalence approaches: Comments by a research-based pharmaceutical company

Statistics in Medicine

Volumn 19, Issue 20, 2000, Pages 2769-2774

  Hauschke, Dieter ^a   Steinijans, Volker W ^a  

^a ALTANA PHARMA AG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG INDUSTRY; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; POPULATION RESEARCH; SAMPLING; STATISTICAL ANALYSIS; UNITED STATES;

CHEMISTRY, PHARMACEUTICAL; GUIDELINES; HUMAN; MODELS, STATISTICAL; RESEARCH DESIGN; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034735555     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001030)19:20<2769::AID-SIM544>3.0.CO;2-8     Document Type: Article

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