Results 101 to 110 of about 9,371 (163)

Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in Healthy Volunteers. [PDF]

open access: yesClin Pharmacol Drug Dev
Schwab D   +7 more
europepmc   +1 more source

Bioequivalence in adults does not mean bioequivalence in children

open access: yes, 2016
Dossche, Lien   +5 more
openaire   +1 more source

ON THE DETERMINATION OF BIOEQUIVALENCE

Pharmacological Research, 1999
The 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, 1990
Current 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, 2011
In 1997, the U.S. Food and Drug Administration (FDA) suggested in its draft guidance the use of new concepts for assessing the bioequivalence of two drug formulations, namely, the concepts of population and individual bioequivalence.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

Home - About - Disclaimer - Privacy