| Title |
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development
|
|---|---|
| Published in |
The AAPS Journal, September 2015
|
| DOI | 10.1208/s12248-015-9820-y |
| Pubmed ID | |
| Authors |
Darshana Jani, John Allinson, Flora Berisha, Kyra J. Cowan, Viswanath Devanarayan, Carol Gleason, Andreas Jeromin, Steve Keller, Masood U. Khan, Bill Nowatzke, Paul Rhyne, Laurie Stephen |
| Abstract |
Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-for-purpose-based validation, emphasizing issues that are unique to multiplex kit assays. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 116 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | <1% |
| Unknown | 115 | 99% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 28 | 24% |
| Other | 17 | 15% |
| Student > Ph. D. Student | 9 | 8% |
| Student > Master | 7 | 6% |
| Student > Bachelor | 5 | 4% |
| Other | 10 | 9% |
| Unknown | 40 | 34% |
| Readers by discipline | Count | As % |
|---|---|---|
| Biochemistry, Genetics and Molecular Biology | 21 | 18% |
| Pharmacology, Toxicology and Pharmaceutical Science | 11 | 9% |
| Medicine and Dentistry | 8 | 7% |
| Agricultural and Biological Sciences | 6 | 5% |
| Chemistry | 6 | 5% |
| Other | 22 | 19% |
| Unknown | 42 | 36% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 October 2015.
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#18,428,159
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Outputs from The AAPS Journal
#1,101
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of 245,081 outputs
Outputs of similar age from The AAPS Journal
#19
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