Toxicology SIG



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


Who we are

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

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

We discuss diverse topics ranging from Dog Telemetry data analysis to Decision Trees, from Bayesian methods to dealing with irate study directors, and now have a list of over 50 affiliates on our e-mail distribution list.

How to get in touch

Join our mailing list by e-mailing this address with brief details of the field(s) you are working in.  

Latest News

We are excited to announce that we will be running a workshop in 2019. It will be on the 2nd and 3rd April at the Crowne Plaza Hotel near Heathrow .

The topics selected for the agenda this year include:

  • Bayesian approaches in pre-clinical
  • Brainstorming to prepare a paper on statistical approaches in Toxicology/Safety Assessment studies
  • Translation between pre-clinical and clinical
  • Exploration of new areas where we can have an impact (eg Data Sciences, Big Data, Machine Learning…)

All this, including overnight accommodation, dinner, breakfast and refreshments during the 2 days, is available for £205 per delegate.


Registration is open and spaces are limited.

To Register click here

Upcoming Events

The PSI Special Interest Group “Toxicology” have a series of regular FREE webinars dealing with statistical topics faced in toxicology and related fields. The presentations will run for an hour, with approximately 45 min presentation and a Q&A session in the remaining time. See section below for details of this years seminars.


Since our inauguration in 2006 we have run a workshop approximately every 18 months. Our last workshop was run on the 24-25 April 2018 at the Crowne Plaza Hotel near Heathrow. The agenda focused on five topics: 

  • Self admin/abuse potential
  • Statistical methods for analysing the Ames-test
  • Role of the  Non-Clinical Statistician
  • Bio-Assay Validation
  • Statistics in Safety Testing
You can find all the slides under the PSI Resources page searching for: > Toxicology Sig > TOX SIG Workshop 2018 



The PSI Special Interest Group “Toxicology” seminars for 2019 are as follows: 




19 Feb 2019

Data Quality and Pre-Clinical Research

Professor Malcolm Macleod     

16 April 2019

ICH S1 revision and CAD process


18 June 2019

The Pig-a-Assay

Scientist(s) from Covance

17 Sept 2019

10 Dec 2019


To Register for a webinar please click on the link once it is available.

For all previous webinars click here.


EventsFuture Events

  • A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians - Dates: 16 – 16 Sep, 2019

    This 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.
  • PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 04 – 04 Jul, 2019

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
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