Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment-Reference-Cited by-同舟云学术

Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment

Published:2021-02-01 Issue:1 Volume:31 Page:7-20
ISSN:2159-3337
Container-title:Nucleic Acid Therapeutics
language:en
Short-container-title:Nucleic Acid Therapeutics

Author:

Tessier Yann¹,Achanzar William²,Mihalcik Lauren³,Amuzie Chidozie⁴,Andersson Patrik⁵,Parry Joel D.⁶,Moggs Jonathan⁷,Whiteley Laurence O.⁸

Affiliation:

1. Pharmaceutical Sciences, Roche Pharma Research and Early Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

2. Drug Safety Evaluation, Bristol Myers Squibb Company, New Brunswick, New Jersey, USA.

3. Amgen Research, Translational Safety & Bioanalytical Sciences, South San Francisco, California, USA.

4. Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, Pennsylvania, USA.

5. Respiratory and Immunology Safety, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.

6. Nonclinical Safety, GSK R&D, David Jack Centre for R&D, Ware, United Kingdom.

7. Preclinical Safety, Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.

8. Pfizer Drug Safety Research and Development, Cambridge, Massachusetts, USA.

Publisher

Mary Ann Liebert Inc

Subject

Drug Discovery,Genetics,Molecular Biology,Molecular Medicine,Biochemistry

Link

https://www.liebertpub.com/doi/pdf/10.1089/nat.2020.0892

Reference31 articles.

1. The Oligonucleotide Safety Working Group (OSWG)

2. RNA-Targeted Therapeutics

3. Assessing unintended hybridization-induced biological effects of oligonucleotides

4. OSWG Recommendations for Genotoxicity Testing of Novel Oligonucleotide-Based Therapeutics

5. Exposure to siRNA-GalNAc Conjugates in Systems of the Standard Test Battery for Genotoxicity

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