QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT

  • Rumel Dey
  • D.R. Chowdhury

Abstract

Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development.

Keywords: Food and Drug Administration (FDA), Quality by Design (QbD).

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References

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How to Cite
Dey, R., and D. Chowdhury. “QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 2, Feb. 2018, pp. 8-16, doi:10.22270/ijdra.v3i2.163.