Transcription of Non-clinical Assessment Requirements
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Non-clinical Assessment Requirements
An agency of the European UnionNon- clinical Assessment RequirementsPresented by: Maria Nieto-GutierrezSafety and Efficacy of Medicines/Human Medicines Development and EvaluationNon- clinical Assessment Requirements1 Non-clinical Assessment RequirementsContents: Relevance of Non-clinical studies in drug development Non-clinical Requirements in the EU pharmaceutical legislation Non-clinical guidelines Non-clinical Assessment within the centralised procedure Support on Non-clinical matters - Safety Working PartyNon- clinical Assessment Requirements2 Non-clinical Assessment RequirementsContents: Relevance of Non-clinical studies in drug development Non-clinical Requirements in the EU pharmaceutical legislation Non-clinical guidelines Non-clinical Assessment within the centralised procedure Support on Non-clinical matters - Safety Working PartyNon- clinical Assessment Requirements3 Relevance of Non-clinical Studies in Drug DevelopmentBasic Goals:- Identify the pharmacological propertiesPD (mode of action)PK (metabolism)Comparative physiology (extrapolation of animal data to humans)- Understand the toxicological profileEstablish a safe initial dose level of the first human exposureIdentify parameters for clinical monitoring of potential adverse effectsSpecia
13. Non-clinical Assessment Requirements • Guidelines are state of the art documents that describe the specific recommendations on how to fulfil the requirements stated by the law
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