Bioassay Analysis
Parallel-line assay
PQ
Software for Biostatistical Analysis
Interpolation analysis
Effective-concentration calculation (EC50)
European Pharmacopoeia
Performance Qualification
<1033>
Equivalence margin development
Operational Qualification
Equivalence Margins
Curve comparisons
binary assay
Slope-Ratio Assays
quantal response assay
Linearity-of-dilution assessment
Outlier Detection
Acceptance Tests
Combination calculation
Information Technology
OQ
US Pharmacopeia
Control Charting
Good Manufacturing Practice
Nonlinear quantitative response assay
IQ
Bioassay Software
<1034>
GMP
<111>
statistical process control
<1032>
Complex Database Applications
Customizable Software
Compliance with FDA 21 CFR Part 11
Dichotomous assay
Software
Installation Qualification
Software for Digital Archives
Equivalence Tests
Software for Dose-Response Analysis
Spike-and-recovery analysis