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| Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry | |||
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| 분류 | Biopharmaceutics, Guidance | 조회 | 2507 |
| 발행년도 | 2015 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/or abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets and capsules that contain highly soluble drug substances.
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