Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Dudal, Sherri; Baltrukonis, Daniel; Crisino, Rebecca M; Goyal, Mahima; Joyce, Alison; Österlund, Karolina; Smeraglia, John; Taniguchi, Yoshihiro; Yang, Jihong

doi:10.1208/s12248-013-9552-9

Cited by 38 publications

(26 citation statements)

References 22 publications

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“…If results from more than one lab shall be evaluated together, homogeneous, well-defined, validated protocols are a clear precondition. In addition, revalidation in all participating labs is advisable or proper method transfer is necessary [121]. These statements are particularly valid, if databases should be fed with data from various sources.…”

Section: Cell-based Assaysmentioning

confidence: 99%

“…The number of possible approaches is large, and there are few scientists, which have experiences with several of them. Every technique has its advantages [97,98,121] as was discussed in the respective sections. In the following well-suited approaches with respect to selected criteria are given (see ''The requirements'' and ''Choice of the right assay'' sections):…”

Section: General Comparison Of Assaysmentioning

confidence: 99%

“…The respective benchmark techniques have been listed in the previous paragraph. The following optimization concepts are widely accepted to ensure the quality of pharmaceuticals in a regulated environment, see [121]. The same concepts can be applied to LBAs.…”

Section: Optimizing Assaysmentioning

confidence: 99%

“…These are samples with known properties that are analyzed together with the samples under study. About 5 % of all samples should be QC samples [121].…”

Section: Avoiding Common Error Sourcesmentioning

confidence: 99%

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Data quality in drug discovery: the role of analytical performance in ligand binding assays

Wätzig

Oltmann-Norden

Steinicke

et al. 2015

J Comput Aided Mol Des

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Despite its importance and all the considerable efforts made, the progress in drug discovery is limited. One main reason for this is the partly questionable data quality. Models relating biological activity and structures and in silico predictions rely on precisely and accurately measured binding data. However, these data vary so strongly, such that only variations by orders of magnitude are considered as unreliable. This can certainly be improved considering the high analytical performance in pharmaceutical quality control. Thus the principles, properties and performances of biochemical and cell-based assays are revisited and evaluated. In the part of biochemical assays immunoassays, fluorescence assays, surface plasmon resonance, isothermal calorimetry, nuclear magnetic resonance and affinity capillary electrophoresis are discussed in details, in addition radiation-based ligand binding assays, mass spectrometry, atomic force microscopy and microscale thermophoresis are briefly evaluated. In addition, general sources of error, such as solvent, dilution, sample pretreatment and the quality of reagents and reference materials are discussed. Biochemical assays can be optimized to provide good accuracy and precision (e.g. percental relative standard deviation <10 %). Cell-based assays are often considered superior related to the biological significance, however, typically they cannot still be considered as really quantitative, in particular when results are compared over longer periods of time or between laboratories. A very careful choice of assays is therefore recommended. Strategies to further optimize assays are outlined, considering the evaluation and the decrease of the relevant error sources. Analytical performance and data quality are still advancing and will further advance the progress in drug development.

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Section: Cell-based Assaysmentioning

confidence: 99%

Section: General Comparison Of Assaysmentioning

confidence: 99%

Section: Optimizing Assaysmentioning

confidence: 99%

“…These are samples with known properties that are analyzed together with the samples under study. About 5 % of all samples should be QC samples [121].…”

Section: Avoiding Common Error Sourcesmentioning

confidence: 99%

See 2 more Smart Citations

Data quality in drug discovery: the role of analytical performance in ligand binding assays

Wätzig

Oltmann-Norden

Steinicke

et al. 2015

J Comput Aided Mol Des

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“…The software has security and access control functions to ensure data access is compliant with United States Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 11, and the data may be exported and analyzed in a standard bioanalytical database, such as the Laboratory Information Management System (LIMS). Other considerations for using the Erenna® platform in a Good Laboratory Practice (GLP) environment are described elsewhere (19).…”

Section: Single Molecule Counting (Smc™)mentioning

confidence: 99%

Emerging Technologies to Increase Ligand Binding Assay Sensitivity

Fischer¹,

Joyce

Spengler³

et al. 2014

AAPS J

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Recent Technological Developments in the Diagnosis and Treatment of Cerebral Edema

Deshmukh

Dabbagh

Jiang

et al. 2021

Advanced NanoBiomed Research

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Latest technological advancements in neurocritical care have translated to improved clinical outcomes and have paved the way for the effective diagnosis and treatment of cerebral edema. Effective management of cerebral edema has the potential to provide a personalized treatment by obtaining the complete pathophysiological information of the patient. The aims of this review are to inform the reader about the research and development in this field in the past decade as well as the materialization of scientific literature through patents. There is a growing interest in multimodal monitoring of the diseased brain as it provides a necessary means to implement effective intervention strategies. Although there is a gradual shift toward the adoption of noninvasive devices for research purposes, their clinical applications are hindered by their inaccuracies. However, the inherent risk of complication and high costs of implementation challenge the status quo. The role of neuroprotectants is explored and the combination of neurodiagnostic and neuroprotective approaches is proposed. Finally, the impacts of the current state of global affairs are discussed and it is predicted that the rising number of traumatic brain injury patents will inevitably translate to improvements in technologies to effectively address cerebral edema.

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Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Cited by 38 publications

References 22 publications

Data quality in drug discovery: the role of analytical performance in ligand binding assays

Data quality in drug discovery: the role of analytical performance in ligand binding assays

Emerging Technologies to Increase Ligand Binding Assay Sensitivity

Recent Technological Developments in the Diagnosis and Treatment of Cerebral Edema

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