Advanced Therapies and Regulatory Framework in Different Areas of the Globe: Past, Present, and Future
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Title
Advanced Therapies and Regulatory Framework in Different Areas of the Globe: Past, Present, and Future
Authors
Keywords
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Journal
CLINICAL THERAPEUTICS
Volume -, Issue -, Pages -
Publisher
Elsevier BV
Online
2021-04-21
DOI
10.1016/j.clinthera.2021.02.006
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- (2019) Natalie Kofler NATURE
- Innovation and competition in advanced therapy medicinal products
- (2019) Enrique Seoane‐Vazquez et al. EMBO Molecular Medicine
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- Regulations on cell therapy products in China: a brief history and current status
- (2019) Yijia Li et al. Regenerative Medicine
- Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
- (2019) Carolina Iglesias-López et al. Frontiers in Pharmacology
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- (2019) Martina Schuessler‐Lenz et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- The technical risks of human gene editing
- (2019) Benjamin Davies HUMAN REPRODUCTION
- A few ethical issues in translational research for gene and cell therapy
- (2019) Luciana Riva et al. Journal of Translational Medicine
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- (2018) Kiyoshi Okada et al. CLINICAL THERAPEUTICS
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- Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe
- (2018) Renske M.T. ten Ham et al. Molecular Therapy-Methods & Clinical Development
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- (2016) Rodolphe Bourret et al. Stem Cell Research & Therapy
- Defibrotide (Defitelio): A New Addition to the Stockpile of Food and Drug Administration-approved Oligonucleotide Drugs
- (2016) Cy Stein et al. Molecular Therapy-Nucleic Acids
- Viral Vectors for Gene Therapy: Translational and Clinical Outlook
- (2015) Melissa A. Kotterman et al. Annual Review of Biomedical Engineering
- Conditional Approval: Japan Lowers the Bar for Regenerative Medicine Products
- (2015) Douglas Sipp Cell Stem Cell
- Linear polyethylenimine-plasmid DNA nanoparticles are ototoxic to the cultured sensory epithelium of neonatal mice
- (2015) HAN ZHOU et al. Molecular Medicine Reports
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