Query regarding bioequivalence study design
Correspondence from ANMAT regarding ANMAT-2020-0035. Type: question. Risk: high. Category: Clinical.
Correspondence ID
COR-335
Type
question
Application
Authority
ANMAT
Category
Clinical
Risk
High
Due Date
2025-01-26
Status
Overdue
Owner
Marcus Webb
Created
2023-01-29
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0035, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.