Excipient Usage Technical Risk Assessment for Generic Solid Dose Products
This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management o...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
International Pharmaceutical Excipients Council
2017-09-01
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| Series: | Journal of Excipients and Food Chemicals |
| Subjects: | |
| Online Access: | https://jefc.scholasticahq.com/article/2576-excipient-usage-technical-risk-assessment-for-generic-solid-dose-products |