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Quality by Design and Process Analytical Technology for Sterile Products—Where Are We Now?
Quality by design (QbD) and process analytical technology (PAT) have become priorities for the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Numerous recent initiatives within CDER and FDA have had the objective of encouraging the pharmaceutical industry t...
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| Autors principals: | , |
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| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
Springer US
2010
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| Matèries: | |
| Accés en línia: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3066341/ https://ncbi.nlm.nih.gov/pubmed/21181513 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-010-9566-x |
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