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. Author manuscript; available in PMC: 2017 Jun 1.
Published in final edited form as: Mol Nutr Food Res. 2016 Jan 29;60(6):1342–1353. doi: 10.1002/mnfr.201500756

Table 3.

Proposed actions for developing WS as a chemopreventive agent in human populations

Phase Action items
Agricultural
  • -

    Bulk production

  • -

    Pest control

  • -

    Contamination
  • -

    Identifying optimal chemotype variants of WS

  • -

    Promoting minimal usage of fertilizer and pesticides

  • -

    Utilizing fields that are low in heavy metal contamination to grow WS

  • -

    Devising novel in vitro root/ leaf culture technologies
Quality control
  • -

    Extraction

  • -

    Quantification
  • -

    Incorporating efficient methods of extraction

  • -

    Completely quantifying percent withanolides and other components
Pre-clinical
  • -

    Potency/efficacy

  • -

    Side effects
  • -

    Screening for potency in cell and animal models using activation of biological pathways validated in chemoprevention

  • -

    Establishing a safe dosing protocol
Clinical
  • -

    Identify population

  • -

    Administer

  • -

    Monitor
  • -

    Identifying suitable at risk populations for cancer, preferably within regions of the world were WS is used in traditional medicine

  • -

    Treating with WS as per findings from pre-clinical studies

  • -

    Observing for 1) biomarkers of WA-mediated pathway activation 2) withanolides in blood or urine

  • -

    Long-term monitoring for modulation of biomarkers or lowered incidence of malignancies