Quality by Design for Generic Drugs - Pharmaceutical Technology

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Quality by Design for Generic Drugs
The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Pharmaceutical Technology
Volume 33, Issue 10, pp. 122-127


1. ICH, ICH Q8(R1) Pharmaceutical Development/Annex (Geneva, November 2008).

2. L. X. Yu. "Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control," Pharm. Res. 25 (4), 781–791 (2008).

3. R. Lionberger et al., "Quality by Design: Concepts for ANDAs," The AAPS Journal. 10 (2), 268–276 (2008).

4. L. S. Lee, A. Raw, and L. X. Yu, "Dissolution Testing," in Biopharmaceutics Applications in Drug Development, R. Krishna and Lawrence X. Yu, Eds. (Springer, New York, NY, 2008), pp. 47–74.

5. ICH, ICH Q9 Quality Risk Management (Geneva, November 2005).

6. ICH Quality Implementation Working Group, Q8, Q9, and Q10 Questions and Answers, http://www.ich.org/LOB/media/MEDIA5290.pdf, accessed Aug. 26, 2009.


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