Why did the quality-by-design (QbD) approach fail? One reason: Lack of availability of relevant and reliable data reflecting the “quality” of products (tablets/capsules).

Recently I participated in a discussion on a LinkedIn forum (Quality by Design or QbD) explaining the relevance and the critical importance of drug dissolution testing for QbD, manufacturing of the products (tablet/capsules), and their evaluations.

Continuing on the topic, I believe a better organized explanation may be useful in clarifying issues related to the assessment of the quality of pharmaceutical products. This article provides the explanation. It is important to note that the following discussion is restricted to tablet and capsule products only. Please click here for the complete article

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