10. Conclusions

The non-clinical development phase is critical and must foresee any possible problems before a medicine candidate moves to the clinical development phase (clinical studies done in people).

Before a medicine can be tested in clinical studies the following must be ensured:
  • Non-clinical safety is evaluated under GLP condition.
  • Manufacturing of both, active substance and medicinal product, is executed under proper quality control.
  • Data and process are documented according to CTD format. And they build the foundation for the clinical development phase.

Researchers tend more and more to design medicine-like properties in-silico, and also to use bioinformatics methods for modelling and prediction.

The non-clinical process is complex for different reasons:
  • The use of new pathology models, which include transgenic animals, can aid some stages of preclinical studies. There is a a lack of biomarkers for organ toxicity which is a serious drawback of the present system. A biomarker is a molecule found in body fluids, for example in blood, or in tissues. It is a sign of an abnormal or normal process, a disease or a condition. It can be used to see how well the body responds to a treatment. The lack of biomarkers is especially evident within myocardial infarction tissue damage, liver toxicity and nephrotoxicity.
  • The project development teams must coordinate in an effective and timely manner.
  • The project teams usually develop a TPP to frame the non-clinical development programme and thereby to focus on key medicinal product criteria as well as to take Go/NoGo decisions in a timely manner.
  • Project management requires scientific, technical, legal and regulatory knowledge.

The main regulatory authorities (The EMA in Europe; the FDA in the US and the PMDA in Japan) keep harmonising or unifying the guidelines for non-clinical development, and they focus on safety and quality. The ICH (www.ich.org) issues detailed guidance from time to time for the pharmaceutical industry. These are similar to the guidelines that are published by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).