Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis
Pharmaceutical Technology
OCTOBER 25, 2022
Companies can save valuable time and resources as well by taking advantage of the FDA’s 505(b)(2) approval pathway. Theoretically, at least, there should be a cost advantage in the production of a single FDC drug compared to the costs of manufacturing, analysing, testing, packaging, and marketing two or three individual products.
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