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Article: Generic industry on board with QbR; 50 QbR ANDAs by 20 firms in the pipeline, OGD's Wu says.(CMC)
- Article from:
- Validation Times
- Article date:
- October 1, 2006
- Author:
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BETHESDA, MD -- Question-based-review (QbR) for generic drugs--to be fully implemented in 2007--is embodied by the quality-by-design (QbD) effort, and is unique because the target product quality profile is well defined, such as, dissolution, purity, uniformity and stability, and there is an extensive formulation and manufacturing experience already available, an FDAer said here Oct. 19.
Lawrence Wu, Ph.D., director for science at the agency's Office of Generic Drugs, told the GPhA technical conference that in QbR, biopharmaceutical properties, including polymorphism, absorption and pharmacokinetics information are known.
Wu stated that the generic drug ...