BIOASSAY

•  Bioassay Design, optimization, validation, reference standard control, process control.
•  Model selection, management of outliers.
• Techniques to measure and increase precision.
• Plate uniformity analyses.
  
• Relative accuracy and dilutional linearity.
• Statistical support for all stages of assay qualification and validation
• Application of US Pharmacopaei, FDA, CDER and ICH Guidances.