I recommend you  "Ilya Kuselman - ResearchGate"

Dear Joseph Dubrovkin, Thank you!

It is a very broad question. Nature Methods has a portfolio called "Points of Significance" that can help you with statistical designs.

Process Flow for-

Analytical Method Development with implementation of QbD:

1. Define the Analytical Target Profile (ATP)

Based upon the Voice of the Customer (QC Personnel) i.e. Minimum Systematic Variability & Minimum Inherent Random Variability with Robustness & Ruggedness

2. Determine Critical Performance Attributes (CPAs)

(CPAs : Accuracy (%Recovery), Precision (%Variability within Different Instruments, Different Analysts, Same Laboratory, Different Laboratories) & Robustness (capability of method to remain unaffected by variation in Method Attributes or Method Variables)

3. Risk Assessment of CMAs & CMVs with respect to CPAs

(i.e. Column Length, Internal Diameter, Column Particle Size, Column Temperature, Mobile Phase Buffer Conc., Mobile Phase pH, %Organic in Mobile Phase, Mobile Phase Composition (Proportion of Polar/Non-Polar Solvent Mixture), Gradient Time)

4. Designing of Experiments for Screening (Plackette-Burmann or Fractional Factorial Designs) & Optimization (CCD/BBD RSM or Mixture Designs) & Development of Method Operable Design Region (MODR= Analytical Design Space) with Numeric & Graphical Optimizations

5. Implementation of Control Strategies

(CMA & CMPs with System Suitability Parameters)

6. Continual Method Improvement

through Analysis of Control Charts with Pp, Ppk, Cp, Cpk.