Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 6
Abstract
The online version of the original article can be found at 10.1208/s12248-015-9753-5.
Authors and Affiliations
Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner, Lawrence X. Yu, Robert Lionberger
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Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval
Dose–response analysis is one of the accepted efficacy endpoints to establish effectiveness. The purpose of this research was to inform selection of an appropriate pre-specified primary dose–response anal...
Performance Comparison of Various Maximum Likelihood Nonlinear Mixed-Effects Estimation Methods for Dose–Response Models
The online version of this article (doi:10.1208/s12248-012-9349-2) contains supplementary material, which is available to authorized users.
A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements
The Global Bioanalysis Consortium (GBC) set up an international team to explore the impact of immunogenicity on pharmacokinetic (PK) assessments. The intent of this paper is to define the field and propose best practices...