Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
The online version of this article (doi:10.1208/s12248-014-9661-0) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Helmut Schütz, Detlew Labes, Anders Fuglsang
Keywords
Related Articles
- EP ID EP681736
- DOI 10.1208/s12248-014-9661-0
- Views 91
- Downloads 0
Targeted Delivery Systems for Oligonucleotide Therapeutics
Oligonucleotides including antisense oligonucleotides and siRNA are emerging as promising therapeutic agents against a variety of diseases. Effective delivery of these molecules is critical to their successful clinical a...
Erratum to: Population Pharmacokinetics and Exposure-Uric Acid Analyses After Single and Multiple Doses of ABT-639, a Calcium Channel Blocker, in Healthy Volunteers
The online version of the original article can be found at 10.1208/s12248-014-9709-1.
Confirmatory reanalysis of incurred bioanalytical samples
Bioanalytical methods used to support the drug development process are validated to ensure that they function in the manner in which they are intended. “Incurred” or study samples can vary in their compos...
Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence
The online version of this article (doi:10.1208/s12248-015-9744-6) contains supplementary material, which is available to authorized users.
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development
Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leadi...