A Quality By Design Approach For Longitudinal Quality Attributes
نویسندگان
چکیده
منابع مشابه
A quality by design approach for longitudinal quality attributes.
The concept of quality by design (QbD) as published in ICH-Q8 is currently one of the most recurrent topics in the pharmaceutical literature. This guideline recommends the use of information and prior knowledge gathered during pharmaceutical development studies to provide a scientific rationale for the manufacturing process of a product and provide guarantee of future quality. This poses severa...
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ژورنال
عنوان ژورنال: Journal of Biopharmaceutical Statistics
سال: 2014
ISSN: 1054-3406,1520-5711
DOI: 10.1080/10543406.2014.979197