Drug Absorption Modeling as a Tool to Define the Strategy in Clinical Formulation Development
Journal Title: The AAPS Journal - Year 2009, Vol 11, Issue 1
Abstract
This article inadvertently failed to include two of the theme issue guest editors. The complete listing of the guest editors is shown in this erratum.
Authors and Affiliations
Martin Kuentz
Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms
Bioequivalence (BE) studies are often required to ensure therapeutic equivalence for major product and manufacturing changes. Waiver of a BE study (biowaiver) is highly desired for such changes. Current regulatory guidel...
Next Generation Ligand Binding Assays—Review of Emerging Technologies’ Capabilities to Enhance Throughput and Multiplexing
The purpose of this manuscript is to provide a summary of the evaluation done by the Throughput and Multiplexing subteam on five emerging technologies: Single molecule array (Simoa™), Optimiser™, CyTOF&#x...
Monoamine Transporter Structure, Function, Dynamics, and Drug Discovery: A Computational Perspective
The online version of this article (doi:10.1208/s12248-012-9391-0) contains supplementary material, which is available to authorized users.
Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
The L2 Global Harmonization Team on large molecule specific assay operation for protein bioanalysis in support of pharmacokinetics focused on the following topics: setting up a balanced validation design, specificity tes...
Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications
Dissolution profile comparisons are used by the pharmaceutical industry to assess the similarity in the dissolution characteristics of two formulations to decide whether the implemented changes, usually minor/moderate in...