Spring Intro 2023

03/03/2023

The Nonclinical Overview An assessment of impurities and degradants should be provided (except for biotechnology-derived products). NITROSAMINE IMPURITIES!! See : https://www.gov.uk/guidance/medicines-marketing-authorisation holders-submission-of-nitrosamine-risk-evaluation The quality of batches used in nonclinical studies and their appropriateness compared to clinical batches should be discussed – reference to relevant section in Module 3 can help.

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The Nonclinical Overview The Expert should comment on the treatment-related effects observed in the non-clinical studies in relation to those expected or observed in humans

An assessment of information on novel excipients should be included.

RELEVANT scientific literature and the properties of related or similar products should be taken into account. Note that unlike the Clinical Section of an MAA, copies of relevant papers need not be submitted in the nonclinical modules.

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