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Comparative pharmacokinetic and bioequivalence of nine oral ivermectin formulations in dogs. [PDF]
Kim S +6 more
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Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in Healthy Volunteers. [PDF]
Schwab D +7 more
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Bioequivalence in adults does not mean bioequivalence in children
Dossche, Lien +5 more
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ON THE DETERMINATION OF BIOEQUIVALENCE
Pharmacological Research, 1999The characteristics and advantages of a new method for the determination of bioequivalence are described. This method does not employ AUC or Cmax, therefore it does not depend on a number of assumptions usually needed for the validity of the traditional method.
Aldo Rescigno, A Rescigno
exaly +3 more sources
Consideration of individual bioequivalence
Journal of Pharmacokinetics and Pharmacodynamics, 1990Current procedures for assessing the bioequivalence of two formulations are based on the concept of average bioequivalence. That is, they assess whether the average responses between individuals on the two formulations are similar. Average bioequivalence, however, is not sufficient to guarantee that an individual patient could be expected to respond ...
Walter W Hauck
exaly +3 more sources
The Bootstrap in Bioequivalence Studies
Journal of Biopharmaceutical Statistics, 2011In 1997, the U.S. Food and Drug Administration (FDA) suggested in its draft guidance the use of new concepts for assessing the bioequivalence of two drug formulations, namely, the concepts of population and individual bioequivalence. Aggregate moment-based and probability-based measures of bioequivalence were introduced to derive criteria in order to ...
Iris Pigeot +2 more
exaly +4 more sources

