Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products

Under the Abbreviated New Drug Application pathway, a proposed generic salmon calcitonin nasal spray is required to demonstrate pharmaceutical equivalence and bioequivalence to the brand-name counterpart or the reference listed drug. This review discusses two important aspects of pharmaceutical equi...

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Bibliographic Details
Main Authors: Lee, Sau L., Yu, Lawrence X., Cai, Bing, Johnsons, Gibbes R., Rosenberg, Amy S., Cherney, Barry W., Guo, Wei, Raw, Andre S.
Format: Artigo
Language:Inglês
Published: Springer US 2010
Subjects:
Regulatory Note
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC3032093/
https://ncbi.nlm.nih.gov/pubmed/21052882
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-010-9242-9
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