Basic principles of non-clinical development

4. Overview of non-clinical development

4.1. Objectives of non-clinical development

Non-clinical development should start after a lead development candidate is found. It should answer the following questions, and the answers will come from specific assessments/studies:

  • Does the medicine “work”? → the answer will come from efficacy assessments or efficacy studies.
  • How can the medicinal product be delivered? And how does the body react to it? → these answers will come from the ADME studies  ( Absorption, Distribution, Metabolism and Excretion).
  • Is the medicine safe? → toxicology/safety pharmacology studies will provide the answer.
  • Is the production (manufacture) of the medicinal product viable and can it be controlled?

As mentioned, non-clinical development activities can continue throughout the life cycle of the product.