Non-clinical statistics for research and development

Interview with Sam Gardner

Statisticians support more than just clinical trials in R&D. Some non-clinical areas where statisticians contribute to drug development include:

• Discovery
  • High throughout screening of drug candidates
  • Genomics
• Early Phase
  • Safety studies (animals)
  • Animal models for efficacy
  • In-vitro Analytical methods to predict in-vivo performance
• Mid-late phase
  • Determining manufacturing process targets for clinical trial material (process definition)
  • Determining the best formulation for a drug product
  • Developing robust and accurate analytical methods to assess the quality of the drug substance and drug product
  • Assessing the stability of the drug product
  • Determining the full manufacturing process and the control strategy to ensure high quality (process characterization), including
    • Operating Ranges
    • Determining Critical Process Parameters
    • Developing quality specifications for inputs (drug substance, raw materials) and outputs (drug product specifications)

There are other areas that statisticians can contribute in non-clinical R&D.... basically anywhere you need to generate and evaluate data in R&D, you can find an application of statistics.

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