Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals-Reference-Cited by-同舟云学术

Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals

Published:2021-04-01 Issue:2 Volume:31 Page:114-125
ISSN:2159-3337
Container-title:Nucleic Acid Therapeutics
language:en
Short-container-title:Nucleic Acid Therapeutics

Author:

Hirabayashi Yoko¹,Maki Kazushige²,Kinoshita Kiyoshi³,Nakazawa Takahiro⁴,Obika Satoshi⁵,Naota Misaki²,Watanabe Kazuto³,Suzuki Mutsumi³,Arato Teruyo⁶,Fujisaka Aki⁵⁷,Fueki Osamu²,Ito Kosuke²,Onodera Hiroshi¹

Affiliation:

1. National Institute of Health Sciences, Kawasaki, Japan.

2. Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Japan.

3. The Japan Pharmaceutical Manufacturers Association (JPMA), Chuo-ku, Japan.

4. Open Circle Partners, Kobe, Japan.

5. Graduate School of Pharmaceutical Sciences, Osaka University, Suita, Japan.

6. Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan.

7. Faculty of Pharmacy, Osaka Ohtani University, Tondabayashi, Japan.

Publisher

Mary Ann Liebert Inc

Subject

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