FDA发布含高溶解度原料药速释固体口服制剂溶出度检测与接受标准最终指南
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
FDA宣布发布最终指南《含高溶解度原料药的速释固体口服制剂溶出度检测与接受标准》，为相关制剂生产商提交NDA、IND或ANDA提供建议。指南说明在何种情况下可采用标准释放检测及标准，替代广泛的方法开发和接受标准设定工作。该指南为最终版本，存档编号为FDA-2018-D-2614。
材料说明该最终指南面向含高溶解度原料药的速释固体口服制剂，指出可采用标准释放检测的适用情形。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2018-D-2614
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.” This guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), as appropriate, for orally administered immediate-release (IR) drug products that contain highly soluble drug substances. The guidance is intended to describe when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2018-D-2614.
来源：FDA Pharmaceutical Quality Documents · fda.gov