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Applying the 3Rs to urinalysis assessments in toxicity studies: refining procedures and adopting a case-by-case approach


Registration Details

Event date and time
NC3Rs and ACCP
Central London
white rat in cage

The NC3Rs and the Association for Comparative Clinical Pathology (ACCP) are jointly hosting an in-person workshop to discuss a fresh perspective on the topic of urinalysis assessments in toxicity studies.

ACCP logo

Urinalysis is routinely performed in regulatory toxicology studies. Sample collection usually requires animals to be individually housed in a metabolism cage and/or catheterised, raising animal welfare issues. It is not clear if urinalysis data are being used in practice and how often they play a role in decision-making, as the quality of the data can be highly variable, and there are other assessments (e.g. histopathology) that may provide more detailed and reliable information. 

The aim of this workshop is to bring together experts on toxicology and clinical pathology from the pharmaceutical and agrochemical industries, and regulatory agencies to discuss opportunities to apply the 3Rs to urinalysis assessments in toxicity studies.

The workshop will include introductory talks on methods of urine collection and the value of urinalysis for decision-making, and a series of industry case studies from the pharmaceutical and agrochemical sectors and breakout sessions.

There will be the option to display posters to showcase refined procedures for urine collection, alternative approaches for functional kidney assessments, or specific case studies. If interested, you can submit an abstract (up to 250 words) during the registration process. 

The in-person workshop is free to attend, but registration is essential.

The deadline for registration is Friday 20 October 2023.


Time Agenda item
10.30 – 10.40

Welcome and aims of the meeting

Paul Baldrick (Fortrea, CHAIR)

10.40 – 10.50

Introduction to the ACCP

Joanna Harding (Exscientia)

10.50 – 11.00

Introduction to the NC3Rs

Elisa Passini (NC3Rs)

11.00 – 11.20

Urinalysis in toxicity studies: methods, frequency and purpose

Lorraine Britton (Sequani)

11.20 – 11.40

A clinical pathologist perspective on urinalysis data

Peter Cotton (Independent) 

11.40 – 12.00

Urinalysis: a CRO perspective

Romalie Allen (LabCorp)

12.00 – 13.00 LUNCH
13.00 – 14.30

Industry case studies:

  • Urinalysis does not drive risk assessments for agrochemicals
    Thomas Holmes (ADAMA)
  • The value of urinalysis in subchronic studies for agrochemicals
    Liz McInnes (Syngenta)
  • Evaluation of urinary safety biomarker panel to improve monitoring of preclinical Antisense Oligonucleotide induced tubular kidney toxicity
    Jayati Basak (AstraZeneca)
  • Value of urinalysis in discovery studies and beyond
    Fiona McClure (GSK)
  • The overall value of urinalysis in toxicology 
    studies in Genentech
    Yemi Adedeji (Genentech)
14.30 – 14.45

Introduction to breakout sessions

Paul Baldrick

14.45 – 16.00

Breakout sessions with refreshments:

Group 1:

Are urinalysis assessments necessary in every study or can we move towards a case-by-case approach?

  • What evidence would be required to move towards a case-by-case approach?
  • What data could be collected to provide such evidence?
  • How can we influence change in regulatory guidance?

Group 2:

When urinalysis is considered necessary, how can we refine urine collection?

  • If not default on all studies, which studies/species would be most appropriate?
  • What does add value (e.g. novel biomarkers)?
  • What refinements can we implement (e.g. methods, frequency) to minimise the impact and stress of this procedure for the animals?
16.00 – 16.30 COFFEE BREAK
16.30 – 16.50

Breakout group feedback

Summary of discussions from each group

16.50 – 17.00

Sum up and next steps

Paul Baldrick

17.00 – 18.00


Sponsored by the ACCP