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 61
- Downloads 0
Regional-Dependent Intestinal Permeability and BCS Classification: Elucidation of pH-Related Complexity in Rats Using Pseudoephedrine
Based on its lower Log P value relative to metoprolol, a marker for the low/high-permeability (Peff) class boundary, pseudoephedrine was provisionally classified as BCS low-permeability compound. On the other hand, follo...
Predicting when Biliary Excretion of Parent Drug is a Major Route of Elimination in Humans
The online version of this article (doi:10.1208/s12248-014-9636-1) contains supplementary material, which is available to authorized users.
Simplification of Complex Physiologically Based Pharmacokinetic Models of Monoclonal Antibodies
The online version of this article (doi:10.1208/s12248-014-9591-x) contains supplementary material, which is available to authorized users.
Drug Carriers: Not an Innocent Delivery Man
Biomaterials used as drug carriers are often considered inactive and assumed to have no other roles than modifying pharmacokinetics and biodistribution of a drug. On the other hand, there are several examples in which th...
Physiologically Based Pharmacokinetic Modeling to Investigate Regional Brain Distribution Kinetics in Rats
One of the major challenges in the development of central nervous system (CNS)-targeted drugs is predicting CNS exposure in human from preclinical data. In this study, we present a methodology to investigate brain dispos...