Skip to main content
SpringerLink
Log in

Use of “Big Data” to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products

  • Research Article
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Background

In 2006, a concept paper (ICH S2(R1)) describing the need for revision of the ICH guidelines on genotoxicity testing for new “small molecule” pharmaceuticals (then ICH S2A and ICH S2B) was finalised. As a result, testing strategy has changed, and flexibility has been introduced in the form of two “equally suitable” options for completing the battery of genotoxicity studies required to support clinical development and marketing of new products.

Methods

The TIBCO Spotfire® platform was used to create a specific view of available in-house data on genotoxicity studies conducted to support pharmaceutical product development over a period of approximately 12 years. The available in-house dataset comprised all reportable non-clinical data from Good Laboratory Practice (GLP) compliant and non-GLP/screening studies on regulated products (including pharmaceuticals, industrial chemicals, agrochemicals, and medical devices) across multiple testing sites, in different geographical locations.

Results

The analysis showed clear trends in the numbers and types of genotoxicity studies conducted on small molecule pharmaceutical products during development, which correlated with the changes in the available regulatory guidance over time. More interestingly, where two “equally suitable” options for genotoxicity testing are described in the international guidance, there is a clear preference for ICH S2(R1) Option 1 (70–80% of testing) compared to Option 2 (20–30%).

Conclusion

Use of ‘Big Data’ identified trends in the newer approach to genotoxicity testing by industry in the light of the updated regulatory guidance.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1.
Figure 2.

Similar content being viewed by others

References

  1. McAfee A, Brynjolfsson E, Davenport TH, Patil DJ, Barton D. Big Data: the management revolution. Harv Bus Rev. 2012;90(10):60–8.

    PubMed  Google Scholar 

  2. Marr B. Data strategy—How to profit from a world of big data, analytics and the internet of things. New York: Kogan Page Limited; 2017.

    Google Scholar 

  3. ICH S2(R1). ICH harmonised tripartite guideline. Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. Current step 4 version, dated 9 November 2011.

  4. ICH S2(R1) Concept paper. Final concept paper S2(R1): guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (revision of the ICH S2 guidelines: “guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals” (S2A) and “genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals” (S2B)) 20 September 2006.

  5. ICH S2A—withdrawn. ICH harmonised tripartite guideline S2A: guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals (issued 19 July 1995).

  6. ICH S2B—withdrawn. ICH harmonised tripartite guideline S2B: genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals (issued 16 July 1997).

  7. Wang T, Jacobson-Kram D, Pilaro AM, et al. ICH guidelines: inception, revision and implications for drug development. Tox Sci. 2010;118(2):356–67.

    Article  CAS  Google Scholar 

  8. ICH M3(R2). ICH Harmonised tripartite guideline guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Current step 4 version dated 11 June 2009.

Download references

Funding

No funding sources.

Author information

Authors and Affiliations

  1. Covance Laboratories Ltd, Otley Road, Harrogate, North Yorkshire, HG3 1PY, UK

    Lesley Reeve, Paul Baldrick, Andrew Newell & Scott Templeton

Authors
  1. Lesley Reeve
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Paul Baldrick
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Andrew Newell
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Scott Templeton
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lesley Reeve.

Ethics declarations

Conflict of interest

No conflicts of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Reeve, L., Baldrick, P., Newell, A. et al. Use of “Big Data” to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products. Ther Innov Regul Sci 54, 764–769 (2020). https://doi.org/10.1007/s43441-019-00011-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-019-00011-7

Keywords

Search

Navigation