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Performance Properties of the Population Bioequivalence Approach for In Vitro Delivered Dose for Orally Inhaled Respiratory Products
Regulatory agencies, industry, and academia have acknowledged that in vitro assessments serve a role in establishing bioequivalence for second-entry drug product approvals as well as innovator post-approval drug product changes. For orally inhaled respiratory products (OIPs), the issues of correctly...
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| Main Authors: | , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2013
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3889535/ https://ncbi.nlm.nih.gov/pubmed/24249218 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9543-x |
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