What preclinical (animal) studies are required for FIH (First-In-Human) trials?

Therapy development Non-clinical development
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I’m currently preparing for a clinical FIH study and was wondering which preclinical (animal) studies are essential according to regulations before moving to FIH. I would like to get a complete overview of the required preclinical tests, particularly regarding safety, toxicology, and pharmacokinetics. Where can I find that?

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Hi Rosa, I would recommend to check the ICH guidance:
M3(R2) Step 5 Non-clinical safety studies for conduct of human clinical trials for pharmaceuticals
Kind regards,
Joanna

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The ICH M3 (R2) is very useful. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry to discuss and harmonize scientific and technical aspects of drug registration. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side.

The ICH guidelines are divided in four categories:

  1. Quality guidelines (Q)
  2. Safety guidelines (S)
  3. Efficacy guidelines (E)
  4. Multidisciplinary guidelines (M)

Besides the multidisciplinary M3 on nonclinical safety studies they have severals specific nonclinical safety guidelines for for example biotechnological products and anticancer pharmaceuticals. They are currently working in a guideline for nonclinical safety studies for oligonucleotide-based therapies.

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Dear Rosa,
It really depends on your product. The requirements for small-chemical products are quite different from the requirements of proteins and gene en cellular products.
Searching for the right regulatory guidelines (other than ICH M3(R2) which is already mentioned by Joanna and Marlous) can be quite time consuming. A quick start is offered by the free tool Market Approval Navigator (MAN tool) which contains a search engine that is more versatile and give better results than standard search engines (e.g. Google) or the search engines on the websites of EMA and FDA. You can find the MAN tool here market-approval-navigator

Please note, that some institutes (like UMCs) have a firewall which blocks the access to the tool. A few UMC (LUMC and UMC Utrecht) whitelisted the tool, so researchers in these UMCs can access the tool without problems. An alternative is to use the MAN tool at home from your private internet account.

Let me know if you have access issues.
Kind regards,
Marcel Kenter

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