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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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| Главные авторы: | , , , , , , , |
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| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
Springer US
2010
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| Предметы: | |
| Online-ссылка: | 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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