Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
نویسندگان
چکیده
منابع مشابه
Analysis of a 3-period 2-treatment pharmacokinetic study to assess scaled average bioequivalence
In the past years various approaches for assessing bioequivalence of so-called "highly variable drugs" have been debated. These are drugs whose pharmacokinetic profiles vary considerably when given to the same subject. As a consequence of the high variability, average bioequivalence between two such drugs can only be shown with an unfeasibly high number of subjects. Therefore regulatory agencie...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2014
ISSN: 1550-7416
DOI: 10.1208/s12248-014-9661-0