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Random forest classification is a well known machine learning technique that generates classifiers in the form of an ensemble ("forest") of decision trees. The classification of an input sample is determined by the majority classification by the ensemble. Traditional random forest classifiers can be highly effective, but classification using a random forest(More)
Developing a process that generates robust immunoassays that can be used to support studies with tight timelines is a common challenge for bioanalytical laboratories. Design of experiments (DOEs) is a tool that has been used by many industries for the purpose of optimizing processes. The approach is capable of identifying critical factors and their(More)
BACKGROUND A microfluidic platform-based assay was validated to measure a humanized or fully human IgG in rat serum samples. MATERIALS & METHODS The cumulative assessment for accuracy and precision was performed with three accuracy and precision runs. RESULTS The inter-assay accuracy (mean %bias) ranged from -4.3 to 3.8%, and inter-batch %CV ranged from(More)
Incurred sample reanalysis (ISR) is recommended by regulatory agencies to demonstrate reproducibility of validated methods and provide confidence that methods used in pharmacokinetic and toxicokinetic assessments give reproducible results. For macromolecules to pass ISR, regulatory recommendations require that two thirds of ISR samples be within 30% of the(More)
Formulation changes at later stages of biotherapeutics development require biocomparability (BC) assessment. Using simulation, this study aims to determine the potential effect of bias difference observed between the two formulations after spiking into serum in passing or failing of a critical BC study. An ELISA method with 20% total error was used to(More)
Interest in assessment of collateral flow measurement has resurfaced with the advent of endoscopic lung volume reduction studies, namely valve technologies (eg Emphasys EBV), that achieve volume reduction through lobar isolation. It is currently thought that collateral ventilation could be a contributing factor for endoscopic lung volume reduction failures,(More)
The Hybrid Memory Cube is an early commercial product embodying attributes of future stacked DRAM architectures, namely large capacity, high bandwidth, on-package memory controller, and high speed serial interface. We study the performance and energy of a Gen2 HMC on data-centric workloads through a combination of emulation and execution on an HMC FPGA(More)
Development and validation of ligand binding methods that can measure therapeutic antibodies (TA) accurately and precisely are essential for bioanalysis that supports regulated pharmacokinetic (PK) and toxicokinetic (TK) studies. Non-bead (planar) electrochemiluminescence (ECL) methods are known to have high sensitivity and a wide assay range and are(More)
Manufacturing changes during a biological drug product life cycle occur often; one common change is that of the manufacturing site. Comparability studies may be required to ensure that the changes will not affect the pharmacokinetic properties of the drug. In addition, the bioanalytical method for sample analysis may evolve during the course of drug(More)
BACKGROUND Incurred sample reanalysis (ISR) is the most recent in-study validation parameter that regulatory agencies have mandated to ensure reproducibility of bioanalytical methods supporting pharmacokinetic/toxicokinetic and clinical studies. The present analysis describes five representative case studies for macromolecule therapeutics. METHOD Single(More)