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Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report
This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,”...
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Are the Current Processes and Regulations Fit for Purpose to Deliver Novel Therapies During Pandemics? A Perspective on COVID-19 from the UK
The COVID-19 pandemic was the first ‘stress test’ to assess whether the current regulations in the United Kingdom (UK) are fit for purpose to develop...
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A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer
AbstractAutogene cevumeran is an individualized neoantigen-specific therapy (iNeST) under development for the treatment of various solid tumors. It...
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Fit-for-purpose based testing and validation of antibodies to amino- and carboxy-terminal domains of cannabinoid receptor 1
Specific and selective anti-CB 1 antibodies are among the most powerful research tools to unravel the complex biological processes mediated by the CB 1 ...
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Application of the International System of Radiation Protection in Fit-for-Purpose Assessment of Impacts
The fundamental safety objective is “to protect people and the environment from harmful effects of ionizing radiation” and this needs to be done...
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Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk
Validation of key analytical and functional performance characteristics of in vitro immunogenicity risk assessment assays increases our confidence in...
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Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling
PurposeThe purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics...
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Fit-for-Purpose Quality Control System in Continuous Bioanalysis During Long-Term Pediatric Studies
Pharmacokinetic studies are key to evidence-based pharmacotherapy. The reliability of pharmacokinetic parameters is closely related to the quality of...
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Correction to: Fit-for-Purpose Quality Control System in Continuous Bioanalysis during Long-Term Pediatric Studies
The LENA collaborator list below was not included in the original article.s
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A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance
ND-L02-s0201/BMS-986263 is a lipid nanoparticle (LNP) drug product containing a heat shock protein 47 (HSP47)–specific small interfering ribonucleic...
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Develo** and Validating a Model of Humeral Stem Primary Stability, Intended for In Silico Clinical Trials
In silico clinical trials (ISCT) can contribute to demonstrating a device’s performance via credible computational models applied on virtual cohorts....
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An industry perspective on current QSP trends in drug development
2023 marks the 10th anniversary of Natpara’s submission to the US FDA, which led to the first recorded regulatory interaction where a decision was...
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Practical Characterization Strategies for Comparison, Qualification, and Selection of Cell Viability Detection Methods for Cellular Therapeutic Product Development and Manufacturing
Cellular therapy development and manufacturing has focused on providing novel therapeutic cell-based products for various diseases. The International...
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Patient preferences for the design of a pharmacy-based colorectal cancer screening program
PurposeTo assess preferences for design of a pharmacy-based colorectal cancer (CRC) screening program (PharmFIT™) among screening-eligible adults in...
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Velocity loss is a flawed method for monitoring and prescribing resistance training volume with a free-weight back squat exercise
PurposeThe aim of this study was to examine the goodness of fit, prediction accuracy, and stability of general and individual relationships between...
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Developmental associations between cognition and adaptive behavior in intellectual and developmental disability
BackgroundIntellectual and developmental disabilities (IDDs) are associated with both cognitive challenges and difficulties in conceptual, social,...
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A framework for establishing scientific confidence in new approach methodologies
Robust and efficient processes are needed to establish scientific confidence in new approach methodologies (NAMs) if they are to be considered for...
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Early At-Home Measurement of Adalimumab Concentrations to Guide Anti-TNF Precision Dosing: A Pilot Study
Background and ObjectiveUnderdosing of adalimumab can result in non-response and poor disease control in patients with rheumatic disease or...
