Anaiytical and formulation attnbutes

摘要

A generic drug nnanufacturer typically spends much less time preparing on Abbreviated New Drug Application (ANDA) than the New Drug Application (NDA) to establish equivalency to the innovator's product and allow access to the market. For a given drug product, the formulation information is often listed in the package insert of the branded drug, providing valuable formulation information to generic developers. In this two part article generic sterile injectable development processes are discussed . Part 1 of this article discusses several aspects of the development processes including deformulation, API selection, container closure, filter validation and product compatibility studies.