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Guidance for Industry process validation |
관리자 |
작성일20.03.11 |
조회341 |
| [공지] |
Guidance for Industry CGMP guideline of Phase I Investigational drug |
관리자 |
작성일20.03.11 |
조회351 |
| 11 |
Biosafety Guidance for Working with Viral Vectors
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관리자 |
작성일22.08.16 |
조회4,406 |
| 10 |
WHO guidelines on nonclinical evaluation of vaccines
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관리자 |
작성일20.03.06 |
조회873 |
| 9 |
vol6c_guidance on ERA_GMO
|
관리자 |
작성일20.03.06 |
조회11,613 |
| 8 |
Overview of comments on _Guideline on the quality, nonclinical and clinical aspects 4 of gene therapy medicinal products
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관리자 |
작성일20.03.06 |
조회924 |
| 7 |
ICH guideline Q11 on development and manufacture of drug substances chemical entities and biotechnological biological entities
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관리자 |
작성일20.03.06 |
조회710 |
| 6 |
GUIDANCE FOR INDUSTRY
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관리자 |
작성일20.03.06 |
조회373 |
| 5 |
FDA guideline for Environmental assessment IND approval
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관리자 |
작성일20.03.06 |
조회349 |
| 4 |
Drug Master Files Guidance for Industry
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관리자 |
작성일20.03.06 |
조회352 |
| 3 |
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports Guidance for Industry
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관리자 |
작성일20.03.06 |
조회413 |
| 2 |
Preclinical Assessment of Investigational Cellular and Gene Therapy Products
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관리자 |
작성일20.02.20 |
조회515 |
