Editorial: The Role of DoE in Early Phase Development

Alcami recently authored an article featured in Manufacturing Chemist titled "The role of DoE in early phase development" Classically, the use of Design of Experiments (DoE) has been heavily leveraged in the pharmaceutical industry in late stage development to support a Quality by Design (QBD) approach to process validation At the heart of the QbD...

ManufacturingChemist_MayIssueAlcami recently authored an article featured in Manufacturing Chemist titled "The role of DoE in early phase development"

Classically, the use of Design of Experiments (DoE) has been heavily leveraged in the pharmaceutical industry in late stage development to support a Quality by Design (QBD) approach to process validation

At the heart of the QbD movement is a data based understanding of the design space of your process — rather than just the empirical support of release testing — to know that the product being made is of consistently high quality. However, because of the association of QbD with expansive data generation and process validation, there is a perceived negative implication to development cost and timing. 



Source: www.alcaminow.com