The Delivery of Flexibility from the Application of QbD to API Development
| Autor: | Phil J. Borman, John Lepore, Sushil K. Srivastava, Nathan D. Ide, John Donaubauer, Steven Tymonko, Matt E. Popkin, Lindsay A. Hobson, Kevin D. Seibert, Timothy Curran, Batool Ahmed Omer, Jeffrey M. Kallemeyn, Looker Adam |
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| Rok vydání: | 2018 |
| Předmět: |
Flexibility (engineering)
Process management Computer science Pharmacology toxicology Control (management) Pharmaceutical Science 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Development (topology) Drug Discovery Change management (engineering) API MANUFACTURE 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical Innovation. 13:367-372 |
| ISSN: | 1939-8042 1872-5120 |
| Popis: | This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility through differentiated outcomes for elements of API manufacture, such as the control strategy and lifecycle change management. Two further articles, in addition to this introductory paper, will present a series of case histories which address such flexibility and exemplify opportunities for the further development of the ICH Q11 vision. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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