Module 5 Presentations

05/07/2024

Overall Benefit/Risk (536/2014) 1. Integrated summary critically

analysing available non-clin & clin data 2. If prematurely terminated studies, these should be identified, justified 3. Safety margins in terms of AUC or C max to be discussed where relevant rather than just proposed dose 4. Clinical relevance of non-clinical findings to be highlighted Try for concise - one to two pages advised

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BfArM Benefit/Risk Recommendations

1. The intended exposure of patients to the IMP and its metabolites (dosage or plasma concentrations) in relation to the exposures at which relevant effects in the pre-clin and clin investigations on PD, tox as well as efficacy and tolerance have been ascertained (including the statement on safety factors, if expedient) 2. Dose-effect relationships and dose-tox relationships, as well as optimal dose ranges including justification for the dosages intended in the CT 3. Efficacy and safety in particular populations (for example gender, age, organ function, illnesses, genetic polymorphisms) 4. Findings from investigations on interactions with other drugs relevant to the study population or con-meds anticipated 5. Necessary supervision, on the basis of the state of knowledge on possible risks for the persons affected 6. Intended measures and criteria for prematurely aborting or interrupting the clinical trial, should it become necessary

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