동향
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| Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations | |||
|---|---|---|---|
| 분류 | Pharmaceutical, IND, NDA | 조회 | 2451 |
| 발행년도 | 2014 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements (referred to as the NDA BA and BE Draft Guidance).
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