New guidelines for the assessment of bioavailability and bioequivalence;Neue Richtlinien für die Beurteilung der Bioverfügbarkeit/Bioäquivalenz

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 48, Issue 5, 2005, Pages 548-555

  Blume, Henning ^a   Schug, B ^a   Tautz, J ^b   Erb, K ^c  

^a SocraTec R and D GmbH   (Germany)

^b Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^c Clinphase Clinical Pharmacology Services   (Germany)

Author keywords

Bioavailability; Bioequivalence; CPMP note for guidance

Indexed keywords

NEW DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONCENTRATION RESPONSE; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DESIGN; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG RESEARCH; DRUG SAFETY; DRUG SOLUBILITY; HUMAN; MAXIMUM ALLOWABLE CONCENTRATION; MEDICAL DECISION MAKING; PHARMACODYNAMICS; PRACTICE GUIDELINE; PROCESS OPTIMIZATION; SYSTEMIC CIRCULATION;

ADMINISTRATION, ORAL; AGE FACTORS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; CONFIDENCE INTERVALS; EUROPE; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; PRACTICE GUIDELINES; SEX FACTORS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 19444386644     PISSN: 14369990     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00103-005-1037-2     Document Type: Article

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