Question on comparative dissolution data
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: information-request. Risk: low. Category: Administrative.
Correspondence ID
COR-329
Type
information-request
Application
Authority
Swissmedic
Category
Administrative
Risk
Low
Due Date
2025-04-26
Status
Draft
Owner
Aisha Okonkwo
Created
2023-08-02
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0029, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.