Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial
Technology transfer step is part of the life cycle of a drug. This stage aims to transfer the information, generated during the development phase, to the industrial manufacturing stage. It must also, generate the necessary knowledge to achieve the efficient implementation of an industrial process tr...
| Main Authors: | , , |
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| Format: | info:eu-repo/semantics/doctoralThesis |
| Language: | spa |
| Published: |
2018
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| Subjects: | |
| Online Access: | https://hdl.handle.net/10171/50970 |
| _version_ | 1793400571987755008 |
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| author | Lassa-Suescun, F. (Fernando) Irache, J.M. (Juan Manuel) Martinez-Galan, F. (Fernando) |
| author_facet | Lassa-Suescun, F. (Fernando) Irache, J.M. (Juan Manuel) Martinez-Galan, F. (Fernando) |
| author_sort | Lassa-Suescun, F. (Fernando) |
| collection | DSpace |
| description | Technology transfer step is part of the life cycle of a drug. This stage aims to transfer the information, generated during the development phase, to the industrial manufacturing stage. It must also, generate the necessary knowledge to achieve the efficient implementation of an industrial process transferred between different industrial plants.
In this study the implementation of an industrial process of tablet manufacturing is carried out identifying, through risk analysis techniques, the process more risky steps (medium or high risk) on which knowledge must be increased, through experiments, until achieve a level of acceptable risk.
Techniques such as OFAT or DOE are used for this purpose. Statistical analysis is applied to the results in order to obtain scientifically based conclusions. Also, it is define the manufacturing process parameters safety zone for this specialty. |
| format | info:eu-repo/semantics/doctoralThesis |
| id | oai:dadun.unav.edu:10171-50970 |
| institution | Universidad de Navarra |
| language | spa |
| publishDate | 2018 |
| record_format | dspace |
| spelling | oai:dadun.unav.edu:10171-509702020-07-21T01:12:48Z Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial Lassa-Suescun, F. (Fernando) Irache, J.M. (Juan Manuel) Martinez-Galan, F. (Fernando) procesos industriales procesos de manipulación de sólidos procesos de tamizado procesos de compresión Materias Investigacion::Farmacia::Farmacia y farmacología Technology transfer step is part of the life cycle of a drug. This stage aims to transfer the information, generated during the development phase, to the industrial manufacturing stage. It must also, generate the necessary knowledge to achieve the efficient implementation of an industrial process transferred between different industrial plants. In this study the implementation of an industrial process of tablet manufacturing is carried out identifying, through risk analysis techniques, the process more risky steps (medium or high risk) on which knowledge must be increased, through experiments, until achieve a level of acceptable risk. Techniques such as OFAT or DOE are used for this purpose. Statistical analysis is applied to the results in order to obtain scientifically based conclusions. Also, it is define the manufacturing process parameters safety zone for this specialty. 2018-04-12T11:13:16Z 2018-04-12T11:13:16Z 2018-04-12 2016-12-14 info:eu-repo/semantics/doctoralThesis https://hdl.handle.net/10171/50970 spa info:eu-repo/semantics/openAccess application/pdf |
| spellingShingle | procesos industriales procesos de manipulación de sólidos procesos de tamizado procesos de compresión Materias Investigacion::Farmacia::Farmacia y farmacología Lassa-Suescun, F. (Fernando) Irache, J.M. (Juan Manuel) Martinez-Galan, F. (Fernando) Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title | Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title_full | Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title_fullStr | Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title_full_unstemmed | Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title_short | Implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| title_sort | implementación de un procedimiento de fabricación de comprimidos de tamoxifeno en planta industrial |
| topic | procesos industriales procesos de manipulación de sólidos procesos de tamizado procesos de compresión Materias Investigacion::Farmacia::Farmacia y farmacología |
| url | https://hdl.handle.net/10171/50970 |
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