Simplifying Bioanalytical Review Using Advanced Computational Techniques

Simplifying Bioanalytical Review Using Advanced Computational Techniques
September 17, 2024 BioData Solutions

Success Highlights

Pharmacokinetic Small Molecule Method Validation Module

Faster reviews: 50% decrease in time to review reports

Reduction in potentially required rework: 2,000% more red flags and 3,500% more yellow flags than manual processes

Increased compliance: Red Thread® checks for 92% FDA guidelines established for Accuracy & Precision, Sensitivity, and Stability tests

Learn more in this case study.

App Notes

Cross-Validation of Statistical Workflow for Cut Point Calculation using Red Thread (Python) Vs R

Cross-Validation of Statistical Workflow for Cut Point Calculation using Red Thread (Python) Vs R

Comparing Cut Points Between Statistical Software Stata and R Using Random Effects Model

Comparing Cut Points Between Statistical Software Stata and R Using Random Effects Model

Case Studies

Simplifying Bioanalytical Review Using Advanced Computational Techniques

Simplifying Bioanalytical Review Using Advanced Computational Techniques

Posters

Assessing the Impact of Ultra-Low Cut Points in Immunogenicity Assays

Assessing the Impact of Ultra-Low Cut Points in Immunogenicity Assays

Singlet Analysis Yields Equivalent Results as Duplicate Analysis in Preclinical Immunogenicity Assessment

Singlet Analysis Yields Equivalent Results as Duplicate Analysis in Preclinical Immunogenicity Assessment

Can Automation Improve Compliance, Consistency, & Efficiency for CGTP Data Analysis

Can Automation Improve Compliance, Consistency, & Efficiency for CGTP Data Analysis

White Papers

Artificial Intelligence increases efficiencies and reduces bias for bioanalytical pharmacokinetic studies and anti-drug antibody statistical determinations

Artificial Intelligence increases efficiencies and reduces bias for bioanalytical pharmacokinetic studies and anti-drug antibody statistical determinations