Read our new complimentaty White Paper on "Three major items to consider when moving from preclinical to clinical development"

Several issues must be considered when planning the preclinical development program of a novel investigational compound such as the nature of the target, the mode of action, the choice of suitable animal models, the identification of pharmacologically effective doses levels, the design of preclinical proof-of-concept studies, and the adequate design of toxicology studies in at least two animal species that are predictive for the situation in humans, et cetera. But there are even more important aspects that are related to regulatory affairs issues.

The early elaboration of a good integrated project plan offers the opportunity to identify the critical path, and an efficient project management can streamline the developmental period. This paper focusses on three major items that should be considered to manage a smooth transition from pre-clinical to clinical research with intent to commence the clinical development program in good time and have it adequately designed to make sure the planning targets Several issues must be considered when planning the preclinical development program of a novel investigational compound such as the nature of the target, the mode of action, the choice of suitable animal models, the identification of pharmacologically effective doses levels, the design of preclinical proof-of-concept studies, and the adequate design of toxicology studies in at least two animal species that are predictive for the situation in humans, et cetera. But there are even more important aspects that are related to regulatory affairs issues. The early elaboration of a good integrated project plan offers the opportunity to identify the critical path, and an efficient project management can streamline the developmental period. This paper focusses on three major items that should be considered to manage a smooth transition from pre-clinical to clinical research with intent to commence the clinical development program in good time and have it adequately designed to make sure the planning targets will be met.

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