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 80
- Downloads 0
Prediction of Exposure–Response Relationships to Support First-in-Human Study Design
In drug development, phase 1 first-in-human studies represent a major milestone as the drug moves from preclinical discovery to clinical development activities. The safety of human subjects is paramount to the conduct of...
Assessment of fertility in male rats after extended chemical castration with a GnRH antagonist
The purpose of this study was to assess whether male rats whose testosterone levels were suppressed to castration levels (<0.5 ng/mL) for a 1-year period by the sustained delivery of orntide acetate, a GnRH antag...
Aggregation Kinetics for IgG1-Based Monoclonal Antibody Therapeutics
Monoclonal antibodies (mAbs) as a class of therapeutic molecules are finding an increasing demand in the biotechnology industry for the treatment of diseases like cancer and multiple sclerosis. A key challenge associated...
A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development
We designed a three-step statistical approach to transfer bioanalytical assays (ELISA and Biacore) which evaluates the (1) average equivalence between the two labs (2) concordance in individual sample results between the...
Evaluation of the Biological Properties and the Enzymatic Stability of Glycosylated Luteinizing Hormone-Releasing Hormone Analogs
The online version of this article (doi:10.1208/s12248-015-9769-x) contains supplementary material, which is available to authorized users.