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| Bioequivalance Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA | |||
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| 분류 | Pharmaceutical, ANDA | 조회 | 2452 |
| 발행년도 | 2013 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance provides recommentdations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements.
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 이전글 |
Bioanalytical Method Validation |
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 다음글 |
Molecular Diagnostic Instruments with Combined Functions |
