The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action
On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment for the approval of innovator (bridging studies, variations, line extensions) and generic medicinal products in the EU came into effect. This revised guideline specifies the requirements for BE assessment for immediate re...
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| 主要な著者: | , |
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| フォーマット: | 図書 |
| 出版事項: |
Frontiers Media S.A.,
2012-06-01T00:00:00Z.
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| 主題: | |
| オンライン･アクセス: | Connect to this object online. |
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| 請求記号: |
A1234.567 |
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| 所蔵 1 | 利用可 |