How To Apply QbD Principles In Clinical Trials

New Drug Approvals

By Frederic L. “Rick” Sax, M.D., global head for the Center for Integrated Drug Development, Quintiles.

The biopharmaceutical manufacturing industry has used quality by design (QbD) principles for decades. The essence of QbD is designing with the end in mind (in this case, the efficient manufacture of a high-quality drug product). This approach emphasizes that the operative word in QbD is not quality, but design.

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