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Nonclinical safety testing of human pharmaceuticals in relation to clinical development

Published on March 31, 2026   29 min

A selection of talks on Pharmaceutical Sciences

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0:00
Hello. I will give you a talk on the ICH guideline M3. I will explain all these terms in the course of my talk. It's about the nonclinical safety testing of human pharmaceuticals in relation to clinical development. I'm Jan Willem van der Laan, Retired. I worked with the Medicines Evaluation Board in Utrecht and in that role, was participating in the ICH for 30 years.
0:32
In Europe, we had some disasters in the clinical trials, which is one in 2016 in France with the BIAL compound BIAL 10-2474, which was a small molecule, but 10 years before, we had a disaster in London with an antibody TGN1412, which was the main reason to write a European guideline about dose selection and all aspects in human trials. That's an important aspect that I will discuss.
1:13
How safe are human medicines? Are there 100% safe medicines? I will discuss the concept of uncertainty, the acceptable adverse effects in relation to benefit and the examples for diseases to be treated, short-term versus long-term, small molecules versus biotech-derived products.
1:35
First, the concept of uncertainty. Developing a drug is reducing uncertainty by gathering knowledge step-by-step. The starting point for a new compound is 100% uncertainty. No data are present at that time. We don't know. We don't know anything about the new drug. In fact, you can see all the gathering of the data as risk mitigation. What are the important strategies first to ensure adequate quality of the investigational medicinal product? The knowledge of the structure and purity is very important. If needed, there are standard animal testing approaches, then you should also conduct additional non-clinical testing to support the relevance of the animal models which have been used. Then apply a scientific rationale in the selection of the starting dose and apply appropriate risk mitigation measures in the design. These risk mitigation measures can be just the signals in the clinical setting. Be aware that 0% uncertainty can never be reached. There's no completely safe drug. So you should always think about what are the remaining risks. That's what we did in the ICH,

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Nonclinical safety testing of human pharmaceuticals in relation to clinical development

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