Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 4
Abstract
A novel format was introduced at the recent AAPS NBC Workshop on Method Development, Validation and Troubleshooting in San Diego on 18th May 2014. The workshop format was initiated by Binodh De Silva; Marie Rock and Sherri Dudal joined the initiative to develop and chair the workshop. Questions were solicited by a variety of avenues, including a Linked-In Discussion Group. Once collated and clarified, the topics covered assay development, validation, and analysis of PK, Immunogenicity, and Biomarkers with an additional topic on alternative bioanalytical technologies. A panel of experts (workshop report co-authors) was assigned to each topic to bring forward thought-provoking aspects of each topic. The format of the workshop was developed to target the needs of bioanalytical scientists with intermediate to advanced experience in the field ranging to enable robust discussion and to delve deeper into the current bioanalytical hot topics. While the new format allowed for an interactive session with the topical discussion driven by the audience members, it did not foster equal discussion time for all of the proposed topics, especially Biomarkers and alternative LBA technologies.
Authors and Affiliations
Marian Kelley, Lauren Stevenson, Michaela Golob, Viswanath Devanarayan, Joao Pedras-Vasconcelos, Roland F. Staack, Rand Jenkins, Brian Booth, Eric Wakshull, Ronald Bowsher, Marie Rock, Sherri Dudal, Binodh DeSilva
Keywords
Related Articles
- EP ID EP680984
- DOI 10.1208/s12248-015-9767-z
- Views 44
- Downloads 0
Sodium-coupled Monocarboxylate Transporters in Normal Tissues and in Cancer
SLC5A8 and SLC5A12 are sodium-coupled monocarboxylate transporters (SMCTs), the former being a high-affinity type and the latter a low-affinity type. Both transport a variety of monocarboxylates in a Na+-coupled manner....
Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents
The online version of this article (doi:10.1208/s12248-012-9334-9) contains supplementary material, which is available to authorized users.
Role of morphine's metabolites in analgesia: Concepts and controversies
The metabolites of morphine, morphine-6-glucuronide (M6G) and morphine-3-glucuronide (M3G), have been extensively studied for their contribution to clinical effects following administration of morphine. Those contributio...
Indolealkylamines: Biotransformations and Potential Drug–Drug Interactions
Indolealkylamine (IAA) drugs are 5-hydroxytryptamine (5-HT or serotonin) analogs that mainly act on the serotonin system. Some IAAs are clinically utilized for antimigraine therapy, whereas other substances are notable a...
Neural retina limits the nonviral gene transfer to retinal pigment epithelium in an in vitro bovine eye model
We investigated the permeation of liposomal and polymeric gene delivery systems through neural retina into retinal pigment epithelium (RPE) and determined the roles of various factors in permeation and subsequent uptake...