Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products-Reference-Cited by-同舟云学术

Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products

Published:2022 Issue:1 Volume:30 Page:13
ISSN:2289-0882
Container-title:Translational and Clinical Pharmacology
language:en
Short-container-title:Transl Clin Pharmacol

Author:

Shin Wonsuk¹^ORCID,Kim Min-Gul²³⁴^ORCID,Kim Anhye¹^ORCID

Affiliation:

1. Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.

2. Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju 54907, Korea.

3. Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju 54907, Korea.

4. Department of Pharmacology, School of Medicine, Jeonbuk National University, Jeonju 54907, Korea.

Funder

Korea Health Industry Development Institute

Publisher

Korean Society for Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical)

Link

https://tcpharm.org/pdf/10.12793/tcp.2022.30.e2

Reference33 articles.

1. Food and Drug Administration. Cellular & gene therapy products [Internet]. Accessed July 9, 2021. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products

2. The case for the use of pooled donors in the manufacture of allogeneic cell therapies

3. The Business Research Company. Cell and gene therapy market global market opportunities and strategies to 2030: COVID-19 growth and change [Internet]. Accessed June, 2021. https://www.bccresearch.com/partners/tbrc-market-briefs/cell-and-gene-therapy-global-market-report.html

4. Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

5. EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

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