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Should the HBEL be re-assessed throughout the phases of development of Investigational Medicinal Products (IMPs)? - Indivirtus - CRO Offers Real Time Cost Effective Solutions.

Should the HBEL be re-assessed throughout the phases of development of Investigational Medicinal Products (IMPs)?

A

Should the HBEL be re-assessed throughout the phases of development of Investigational Medicinal Products (IMPs)?

Health-Based Exposure Limits should be established based on all available data, and particularly as the knowledge base for IMPs is continually evolving the basis for establishing the HBEL, should be regularly reviewed taking account of any new relevant data.

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