Module 9 2024

05/09/2024

Ensuring Assay Sensitivity

⚫ Equivalence trial needs to be carried out in a setting in which the RP is known to work and in which the magnitude of effect is known. ⚫ Thus an equivalence trial needs to be based on an historic reference trial in which the RP has been compared against placebo. ⚫ The therapeutic equivalence trial therefore needs to recruit a similar population who are treated in a similar way to those in the reference trial .

The Organisation for Professionals in Regulatory Affairs

49

Differences observed in maintenance phase but not correction phase

The dosage of the test drug within the last four weeks was approximately 10% higher than the dosage of the reference product

Silapo European Public Assessment Report http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000760/WC500050914.pdf

The Organisation for Professionals in Regulatory Affairs

50

25