동향
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| Waiver of In Vivo Bioavailability and Bioequivalence Studies for mediate-Release Solid Oral Dosage Forms Basedd on a pharmaceutics Classification System | |||
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| 분류 | Pharmaceutics Classification System, Guidance | 조회 | 2429 |
| 발행년도 | 2015 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance provides recommendations for sponsors of investigational new drug applications (INDs), and applicants that submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of in vivo bioavailability (BA) and/or bioequivalence (BE) studies.
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 이전글 |
Acceptance of clinical trials conducted in third countries, for evaluation in marketing-authorisation applications |
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Licensing Radioisotope Production Facilities |
