OSWG Recommendations for Genotoxicity Testing of Novel Oligonucleotide-Based Therapeutics-Reference-Cited by-同舟云学术

OSWG Recommendations for Genotoxicity Testing of Novel Oligonucleotide-Based Therapeutics

Published:2016-04 Issue:2 Volume:26 Page:73-85
ISSN:2159-3337
Container-title:Nucleic Acid Therapeutics
language:en
Short-container-title:Nucleic Acid Therapeutics

Author:

Berman Cindy L.¹,Barros Scott A.²,Galloway Sheila M.³,Kasper Peter⁴,Oleson Frederick B.⁵,Priestley Catherine C.⁶,Sweder Kevin S.⁷,Schlosser Michael J.⁸,Sobol Zhanna⁹

Affiliation:

1. Berman Consulting, Wayland, Massachusetts.

2. Alnylam Pharmaceuticals, Cambridge, Massachusetts.

3. Merck Research Laboratories, West Point, Pennsylvania.

4. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.

5. Consultant, Concord, Massachusetts.

6. AstraZeneca, Innovative Medicines & Early Development, Cambridge, United Kingdom.

7. Forensic and National Security Sciences Institute, Syracuse University, Syracuse, New York.

8. MSR Pharma Services, Inc., Lincolnshire, Illinois.

9. Pfizer, Inc., Groton, Connecticut.

Publisher

Mary Ann Liebert Inc

Subject

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

Link

http://www.liebertpub.com/doi/pdf/10.1089/nat.2015.0534

Reference58 articles.

1. The Oligonucleotide Safety Working Group (OSWG)

2. Nonclinical Safety Assessments and Clinical Pharmacokinetics for Oligonucleotide Therapeutics: A Regulatory Perspective

3. Assessment of the genotoxic potential of ISIS 2302: a phosphorothioate oligodeoxynucleotide

4. Kynamro Prescribing Information. (2013, revised 3, 2015). Cambridge, MA: Genzyme Corporation.

5. Safety Pharmacology and Genotoxicity Evaluation of AVI-4658

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