Can I read ASEAN Biosimilar Registration Guidelines on EtoBox?

ASEAN Biosimilar Registration Guidelines by Brian Williams is a document available to read on EtoBox.

What is ASEAN Biosimilar Registration Guidelines about?

This document outlines clinical data requirements for pharmaceutical registration in ASEAN countries. It provides a table specifying which types of clinical studies are required for different categories of products, including new chemical entities, biotechnological products, major variations, minor variations, generic products, and changes to route of administration, strength/posology, or indication for existing products. The table addresses parameters such as bioavailability/bioequivalence studies, pharmac

Author

Brian Williams

Language

EN