Developmental Strategies and Method Validation of LC-MS-Based Bioanalytical Methods for Oligonucleotide Therapeutics-Reference-Cited by-同舟云学术

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Developmental Strategies and Method Validation of LC-MS-Based Bioanalytical Methods for Oligonucleotide Therapeutics

Published:2023-06-01 Issue:2 Volume:71 Page:62-68
ISSN:1340-8097
Container-title:Journal of the Mass Spectrometry Society of Japan
language:en
Short-container-title:J. Mass Spectrom. Soc. Jpn.

Author:

Sun Yuchen¹,Saito Yoshiro¹

Affiliation:

1. Division of Medicinal Safety Science, National Institute of Health and Sciences

Publisher

The Mass Spectrometry Society of Japan

Subject

General Medicine

Link

https://www.jstage.jst.go.jp/article/massspec/71/2/71_S23-20/_pdf

Reference57 articles.

1. 1) 井上貴雄，Drug Delivery System, 31, 10（2016）.

2. 2) US. FDA, https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20961_Vitravene_pharmr.pdf

3. 3) US. FDA, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-756_Macugen_biopharmr.pdf

4. 4) US. FDA, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000ClinPharmR.pdf

5. 5) US. FDA, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488Orig1s000ClinPharmR.pdf

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