Toxicology SIG

Our mission statement:

To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.

Our membership consists of statisticians at CROs, pharmaceutical companies and academia who are working in preclinical areas such as:

- Acute Tox
- General Tox
- Toxicokinetics
- Repro Tox
- Genetic Tox
- Immuno Tox
- Toxicogenomics
- Histopathology
- Safety Pharmacology
- Carcinogenicity

We discuss topics ranging from Dog Telemetry data analysis to Decision Trees, from Bayesian methods to dealing with irate study directors, and no have a list of over 40 affiliates on our e-mail distribution list.
Join our mailing list by e-mailing this address with brief details of the field(s) you are working in.


In October 2015 we ran our latest Workshop, at Heathrow. The agenda focused on five hot topics in Toxicology: 

  • Analysis of Large Datasets
  • Experimental Design
  • Anti-drug Antibody assays (cut point determination)
  • Benchmark Dose Approach
  • Carcinogenicity study update

Since our inauguration in 2006 we have run these workshops approximately every 18 months, with ad hoc webinar meetings held during the year. We are running the next workshop on 14th and 15th March 2017 at the Crowne Plaza Hotel, Heathrow, UK. To register click here.


Recent Activity

We recently sent out a questionnaire asking about interest in topics for our workshop. The top five topics of interest were:

  1. Repeated measures: In general for all data types (Body weight, activity data, etc.)
  2. Historical Control Data ranges/outliers/control charts
  3. Outlier determination
  4. Carcinogenicity studies:
    - How to deal with treated groups sacrificed earlier than control
    - Impact on label of running transgenic instead of 2 x 2 year studies
  5. How do we empower our scientists to do some routine analyses, whilst also ensuring quality of results?


Latest News

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Workshop 2017

EventsFuture Events

  • Statistics Fundamentals for Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’) - Dates: 14 – 14 Nov, 2017

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.
  • PSI One Day Meeting: Estimands – Examples for Statisticians! - Dates: 27 – 27 Sep, 2017

    The PSI Scientific Committee have put together this one day meeting to provide Statisticians with real world examples of how Estimands have been defined. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask your questions on defining an Estimand.
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Principal Statistician, Clinical Biostatistics


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Biostatistician / Senior Biostatistician


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Senior/Principal Biostatistician