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The degree of predictivity in pilot studies on six subjects in bioequivalence trials

โœ Scribed by Antonio Marzo; Monia Fibbioli; Claudio Marone; Bernard Cerutti


Book ID
119345985
Publisher
Elsevier Science
Year
2004
Tongue
English
Weight
44 KB
Volume
49
Category
Article
ISSN
1043-6618

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Characteristics of the variance component for the subject-by-formulation interaction ( 2 D ), estimated in simulated studies of individual bioequivalence and in three-and four-period cross-over trials reported by the FDA, were compared. 2 D was estimated by (i) restricted maximum likelihood (REML) a