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| Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Tomography (PET) Drugs | |||
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| 분류 | PET, Clinical Trial, Guidance | 조회 | 2383 |
| 발행년도 | 2012 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Similar strategies may also be useful in studies conducted in earlier stages of development.
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 이전글 |
Licensing Radioisotope Production Facilities |
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 다음글 |
Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials |
