Mitigating the Risks of Generic Drug Product Development: An Application of Quality by Design (QbD) and Question based Review (QbR) Approaches.
This paper discusses the challenges and advantages of implementing Quality by Design (QbD) and Question based Review (QbR) when developing solid dosage formulations and manufacturing processes for generic drugs. Formulation and process development of a drug product is challenging due to the inherent...
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| Format: | Article |
| Language: | English |
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International Pharmaceutical Excipients Council
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| Series: | Journal of Excipients and Food Chemicals |
| Online Access: | http://jefc.scholasticahq.com/article/915-mitigating-the-risks-of-generic-drug-product-development-an-application-of-quality-by-design-qbd-and-question-based-review-qbr-approaches.pdf |