How to embrace the qbd paradigm - Patricia Rodriguez
Автор: CPHI Global Pharma Events
Загружено: 2013-12-04
Просмотров: 1533
CPHI 2013
Key objectives of the topic:
Describe, on an example, how to approach pharmaceutical freeze drying from a new perspective, offered by the FDA and EMA QbD initiative.
Abstract:
To facilitate robust processes and pharmaceutical products reliable in terms of patient safety and therapeutic efficacy, FDA and EMA encourage the companies to use the Quality by Design strategy in product development, manufacturing, and control. For this new approach, a pool of scientific knowledge of the product needs to be collected and documented in a sound way.
In this work we describe how to apply the QbD approach in freeze drying, on an antiviral generic product, as a model. We describe how to choose the optimal DoE type, to guarantee both statistically significant data and minimize the number of experiments. The data collected from the experimental work are subject to chemiometric analysis, in order to define a knowledge, operational design space and the control strategy, as the main goal of the QbD process
See more at: http://www.cphi.com/europe/networking...
Доступные форматы для скачивания:
Скачать видео mp4
-
Информация по загрузке:
