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Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications
Dissolution profile comparisons are used by the pharmaceutical industry to assess the similarity in the dissolution characteristics of two formulations to decide whether the implemented changes, usually minor/moderate in nature, will have an impact on the in vitro/in vivo performance of the drug pro...
में बचाया:
| में प्रकाशित: | AAPS J |
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| मुख्य लेखकों: | , , , , , , , , |
| स्वरूप: | Artigo |
| भाषा: | Inglês |
| प्रकाशित: |
Springer US
2016
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| विषय: | |
| ऑनलाइन पहुंच: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5256611/ https://ncbi.nlm.nih.gov/pubmed/26928450 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9893-2 |
| टैग : |
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