• Overview of ICH M10 Guideline on Bioanalytical Method Validation and　Study Sample Analysis
  Akiko ISHII-WATABE, Yoshiro SAITO
  2024 Volume 55 Issue 1 Pages 2-9
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_2
  JOURNAL FREE ACCESS
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• Training Materials of ICH M10 Guideline
  Daisuke IWATA
  2024 Volume 55 Issue 1 Pages 10-11
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_10
  JOURNAL FREE ACCESS
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• Reforming Regulatory Landscape of Bioanalysis: Challenges and Strategies for Pharmaceutical Companies under ICH M10
  Masayo HASHIMOTO
  2024 Volume 55 Issue 1 Pages 12-17
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_12
  JOURNAL FREE ACCESS
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• Bioanalysts’ Discussions and Opinions on ICH M10 Guideline at 2022 JBF Workshop
  Makoto TAKAHASHI
  2024 Volume 55 Issue 1 Pages 18-23
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_18
  JOURNAL FREE ACCESS
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• Bioanalytical Method Validation for New Modalities　– Oligonucleotides and Peptides Containing Non-natural Amino Acids –
  Kosuke SAITO, Yuchen SUN
  2024 Volume 55 Issue 1 Pages 24-34
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_24
  JOURNAL FREE ACCESS
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• [title in Japanese]
  [in Japanese]
  2024 Volume 55 Issue 1 Pages 35-37
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_35
  JOURNAL FREE ACCESS
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• [title in Japanese]
  [in Japanese]
  2024 Volume 55 Issue 1 Pages 38-40
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_38
  JOURNAL FREE ACCESS
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• [title in Japanese]
  [in Japanese]
  2024 Volume 55 Issue 1 Pages 41-43
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_41
  JOURNAL FREE ACCESS
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• [title in Japanese]
  [in Japanese], [in Japanese], [in Japanese], [in Japanese], [in Japane ...
  2024 Volume 55 Issue 1 Pages 44-45
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_44
  JOURNAL FREE ACCESS
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• [title in Japanese]
  [in Japanese]
  2024 Volume 55 Issue 1 Pages 46-49
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_46
  JOURNAL FREE ACCESS
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• Cut-point Determination in Anti-drug Antibody Assay for Biopharmaceuticals
  Kazuko NISHIMURA, Hiroko SHIBATA, Yoshiro SAITO, Akiko ISHII-WATABE
  2024 Volume 55 Issue 1 Pages 50-64
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_50
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• Development of Lead-specific Test Method for the Control of Elemental Impurities in Pharmaceutical Additives Listed in the Japanese Pharmacopoeia
  Yasuhiro ABE, Makoto MATSUMOTO, Shunsuke ZAMA, Makoto GOSHOKUBO, Hirok ...
  2024 Volume 55 Issue 1 Pages 65-72
  Published: 2024
  Released on J-STAGE: February 28, 2024
  
  DOIhttps://doi.org/10.51018/pmdrs.55.1_65
  JOURNAL FREE ACCESS
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