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www.fdanews.com/articles/143011-fda-gives-generic-drug-makers-a-qbd-example-for-modified-release-drugs

FDA Gives Generic-Drug Makers a QbD Example for Modified-Release Drugs

January 13, 2012
The FDA is encouraging generic-drug makers to use quality by design (QbD) for modified-release products by publishing an example of the development, design and manufacturing of a fictitious modified-release drug using QbD principles.
Drug Industry Daily