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
- DMPK
- ECG
- 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.

Workshops

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


  • Patient Engagement in Clinical Trials Webinar - Dates: 13 – 13 Jun, 2017

    Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials.
  • BBS / PSI One-day Event on Cancer Immunotherapy - Dates: 15 Jun, 2017

    This joint Basel Biometric Society / PSI one day meeting will present an overview of the science and potential statistical challenges across a range of topics covering early and late phases of development, regulatory and health technology assessments.
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Associate Director, Biostatistician

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Medical Statistician / Senior Medical Statistician

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Astrazeneca

Associate Director, Statistics Team leader - Early Clinical Development

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Astrazeneca

Early Clinical Development – various levels

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Biostatistics Head of Department

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Astrazeneca

Principal Statistician – Centralised Statistical Monitoring

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Astrazeneca

Clinical Trial Design Methodology Expert - Statistical Innovation Team

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