| Autor: |
Hagen, Anna, Aunins, Anne, Howson, Laura, Janus, Tracy, LeGrow, Kathleen, Robinett, Robin, Thornton, Rachel, Sitrin, Robert |
| Předmět: |
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| Zdroj: |
BioPharm International; Sep2003, Vol. 16 Issue 9, p56, 6p |
| Abstrakt: |
Focuses on the integration of chemistry, manufacturing, and control document preparation in the development process of Investigational New Drug Application (IND) for vaccines. Difficulty of preparing an IND; Validation of assays in preparation of a manufacturable product at commercial scale; Details on the process for the preparation of clinical materials. |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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