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Applied Statistics 

Our dedicated CMC Statisticians offer expertise in study design and analysis, employing robust statistical methodologies. We provide comprehensive statistical analysis, foster partnerships, and seamlessly integrate into our clients' teams. By implementing cutting-edge methodologies and delivering tailored training, we ensure the highest quality standards. We champion recommended best practices and help harmonize techniques throughout your company.

Analyzing the data
Analysing data
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Services include Training and Consulting in:

Fundamentals of Experimentation

  • Conducting informal risk assessments
  • Planning experiments (factors, study ranges, responses, etc.)
  • Measurement and sampling plan
Limits and Comparability 
  • Statistical assumptions; analysis and modeling of the experimental data
  • Process comparability assessment, bridging assays, qualification of new reagents
  • Setting specification limits
  • Outlier analysis​
Upstream Process Development 
(Process Characterization)
  • Quality by design concepts
  • Risk assessment
  • Design of experiments
  • Predictive modeling
  • Model verification
  • Model qualification
  • Model calibration
  • Critical process parameter identification
  • Setting Normal Operating Ranges (NORs) and Proven Acceptable Ranges (PARs)
  • Edge of failure evaluation and design space generation ​

Downstream Process Development 

(Process Characterization)

  • Quality by design concepts
  • Risk assessment
  • Design of experiments
  • Predictive modeling
  • Model verification
  • Model qualification
  • Model calibration
  • Critical process parameter identification
  • Setting Normal Operating Ranges (NORs) and Proven Acceptable Ranges (PARs)
  • Edge of failure evaluation and design space generation
Scale-up
  • Process comparability assessment
Analytical Method Development 
(Regular and Bioassays)
  • Fitness-for-use study (repeatability, bias, linearity, range, LOD/LOQ, specificity)
  • Robustness study (optimization of the assay)
  • Intermediate precision study (Method Validation)
  • Method transfer (from AD to QC)
  • Bridging assays
  • Qualification of new and/or critical reagents
  • Setting acceptance criteria and Operating Ranges 
  • Robotic process automation 
  • Dynamic assay monitoring and evaluation

Drug Substance and Drug Product Formulation

  • Design of experiments
  • ​Formulation optimization
  • Forced degradation studies
Technology Transfer
  • Process comparability assessment
Manufacturing 
  • Setting specification limits for critical quality attributes and process outputs
  • Setting operating ranges 
  • Root cause analysis based on big or small data
  • Multivariate Analysis
  • Dynamic data monitoring and evaluation
  • Continued process verification (CPV) and statistical process control
    • Setting control limits
    • Setting statistical limits, or
    • Setting adjusted limits based on tolerance intervals
    • Control charting, identifying special causes, and trend analysis
    • Process capability and process performance assessment 
  • Robotic process automation 
Quality Control
  • Stability analysis
    • Estimating degradation rates 
    • Setting expiration dates
    • Comparing stability of lots to one another (assessing poolability
    • Dynamic data monitoring and evaluation 
  • ​Statistical process control
    • Setting control limits
    • Setting statistical limits, or
    • Setting adjusted limits based on tolerance intervals
    • Control charting, identifying special causes, and trend analysis
    • Process capability and process performance assessment 
  • Robotic process automation 

© 2019 by IliaCook Statistical Consulting. 

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