Our expertise in biostatistics is broad. Some of our areas for consulting services are listed below.
Analytical methods and bioassays
Chromatographic and spectroscopic methods, ELISA and cell-based bioassays. Standard curves using linear, non-linear, 4-parameter logistic regressions. Qualification of reference materials, standards and critical reagents. Estimation of assay precision (variability) and optimization. Method validation (ICH Q2) and method transfer.
Product, Process and Quality control
Design of experiments, specification setting, stability analysis and shelf-life estimation (Q1E), comparability (Q5E), process capability (Cpk, Ppk) analysis, process validation, continuous process verification strategies, statistical process control (SPC) charts, internal alert (for process consistency) and release (to assure shelf-life or for downstream processing) limits.
Continuous improvement
Variance components (sources of variation) analysis, hypothesis testing, variability reduction.
CMC (regulatory) support
Authoring and reviewing of regulatory submission documents such as justification of specification, shelf-life estimates.
Software development
Besides StabilityPlus™ software, we can develop custom software to suit your specific needs. We have expertise in R, JMP, Minitab, VBA and many programming languages.