QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
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.
2. Shajeeya Amren. SK, Viswanath. A, Srinivasa Babu. P. Quality by Design- Novelty in Pharmaceuticals. World Journal of Pharmaceuticals research. 2013; 2(5):1409-22
3. John G. Lanese. “OOS: The Last Resort”, Pharmaceutical Formulation and Quality, 2011.
4. Agnes Shanley. “From the Editor: The cost of poor quality, Too high a price?”. Pharmaceutical Manufacturing; 2012.
5. Bill Schmidt. “Implementing Quality by Design: Are you ready or not?”www.pharmaqbd.com; 2010.
6. ICH Q8 (R1). Pharmaceutical Development: Quality by Design; 2006.
7. FDA CDER Draft guidance for industry and review staff. Target profile- Strategic development process tool; 2007.
8. ICH Q9- Quality Risk Management, step 4. [Internet]. ICH; 2005 [cited 2015 May 11]. Available from:
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