| [공지] |
Guidance for Industry process validation |
관리자 |
작성일20.03.11 |
조회333 |
| [공지] |
Guidance for Industry CGMP guideline of Phase I Investigational drug |
관리자 |
작성일20.03.11 |
조회344 |
| 11 |
Biosafety Guidance for Working with Viral Vectors
|
관리자 |
작성일22.08.16 |
조회4,387 |
| 10 |
WHO guidelines on nonclinical evaluation of vaccines
|
관리자 |
작성일20.03.06 |
조회854 |
| 9 |
vol6c_guidance on ERA_GMO
|
관리자 |
작성일20.03.06 |
조회11,593 |
| 8 |
Overview of comments on _Guideline on the quality, nonclinical and clinical aspects 4 of gene therapy medicinal products
|
관리자 |
작성일20.03.06 |
조회905 |
| 7 |
ICH guideline Q11 on development and manufacture of drug substances chemical entities and biotechnological biological entities
|
관리자 |
작성일20.03.06 |
조회704 |
| 6 |
GUIDANCE FOR INDUSTRY
|
관리자 |
작성일20.03.06 |
조회367 |
| 5 |
FDA guideline for Environmental assessment IND approval
|
관리자 |
작성일20.03.06 |
조회343 |
| 4 |
Drug Master Files Guidance for Industry
|
관리자 |
작성일20.03.06 |
조회345 |
| 3 |
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports Guidance for Industry
|
관리자 |
작성일20.03.06 |
조회403 |
| 2 |
Preclinical Assessment of Investigational Cellular and Gene Therapy Products
|
관리자 |
작성일20.02.20 |
조회505 |
