The development of all  medicinal products  is a complex process involving  an evaluation of safety performed in animals (pre-clinical studies) and  in  human subjects (human clinical trials).

Aim of pre-clinical studies is to assess   the   potential  toxic effect  of the  tested medicinal products.  The studies have to be adequate to characterise toxic effect under the conditions planned to be used during initial starting dose of trials involving human beings. The data obtined during preclinical  studies should allow to identify parameters used during clinical trials as the monitoring   tools for potential adverse effects.

Human  clinical trials are conducted to demonstrate safety and efficacy of medicinal product  administered in the  increased doses and through increasesd duration and/or size of exposed patient population.

During the presentation, principles of plannining of preclinical studies and human clinical trials conduct based on Scientific Guidelines for Human Medicinal  Products issued by European Medicines Agency (EMEA) will be presented, with a special emphasis on biotechnology and biosimilar products development.

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