Query regarding bioequivalence study design

Correspondence from European Medicines Agency regarding EMA-2023-0042. Type: deficiency. Risk: medium. Category: Quality.

Correspondence ID
COR-042
Type
deficiency
Application
EMA-2023-0042
Authority
European Medicines Agency
Category
Quality
Risk
Medium
Due Date
2024-12-30
Status
Completed
Owner
Carlos Mendez
Created
2022-08-21
Correspondence Body
Dear EMA Review Team, With reference to application EMA-2023-0042, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_42_1.pdfstudy_report_42.pdf
Response Package
Response package assembled: RP-042