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Development and validation of qPCR methods for nucleic acid biomarkers as a drug development tool: points to consider.
Sun, Yuchen; Nakamura, Takahiro; Ohtsu, Yoshiaki; Kakehi, Masaaki; Danno, Noriyuki; Shimizu, Hiroyuki; Tanaka, Yoichi; Serelli-Lee, Victoria; Tanaka, Seiji; Okayama, Takashige; Suda, Yusuke; Moriya, Yuu; Hanada, Takeshi; Saito, Yoshiro.
Affiliation
  • Sun Y; Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, 210-9501, Japan.
  • Nakamura T; Shin Nippon Biomedical Laboratories, Ltd, Kagoshima, 891-1394, Japan.
  • Ohtsu Y; Kyowa Kirin Co., Ltd, Shizuoka, 411-8731, Japan.
  • Kakehi M; Takeda Pharmaceutical Company, Limited, Kanagawa, 251-8555, Japan.
  • Danno N; CMIC Pharma Science Co., Ltd, Yamanashi, 408-0044, Japan.
  • Shimizu H; Mitsubishi Tanabe Pharma Corporation, Kanagawa, 251-8555, Japan.
  • Tanaka Y; Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, 210-9501, Japan.
  • Serelli-Lee V; Eli Lilly Japan KK, Hyogo, 651-0086, Japan.
  • Tanaka S; Clinical evaluation sub-committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, Tokyo, 103-0023, Japan.
  • Okayama T; ASKA Pharmaceutical Co., Ltd, Kanagawa, 251-8555, Japan.
  • Suda Y; Taiho Pharmaceutical Co., Ltd., Ibaraki, 300-2611, Japan.
  • Moriya Y; Nippon Shinyaku Co., Ltd, Kyoto, 601-8550, Japan.
  • Hanada T; Takeda Pharmaceutical Company, Limited, Kanagawa, 251-8555, Japan.
  • Saito Y; Daiichi Sankyo Co., Ltd, Tokyo, 140-8710, Japan.
Bioanalysis ; 15(17): 1069-1081, 2023 Sep.
Article in En | MEDLINE | ID: mdl-37584367
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Real-Time Polymerase Chain Reaction Type of study: Guideline Country/Region as subject: Asia Language: En Journal: Bioanalysis Year: 2023 Type: Article Affiliation country: Japan
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Real-Time Polymerase Chain Reaction Type of study: Guideline Country/Region as subject: Asia Language: En Journal: Bioanalysis Year: 2023 Type: Article Affiliation country: Japan