A study over effects of process parameters on quality attributes of a tablet by applying “quality by design

[摘要] Quality by design is an emerging concept which provides pharmaceutical manufacturer with increased self-regulated flexibility while maintaining tight quality standards and real time release of the product. The concept of QBD was mentioned in the ICH Q8 guidance (3), which states that “quality cannot be tested into products, i.e., quality should be built in by design”. This paper discusses the pharmaceutical quality by design and describes how it can be used to study the effect of process parameters on quality attributes of tablet.

[学科分类] 药理学