Clinical Application Unit

We manage GMP-grade synthesis facilities to produce and serve labeled compounds for clinical studies or clinical trials, including first-in-human studies.

Research Fields

Chemistry / Biology & Biochemistry / Molecular Biology & Genetics / Immunology / Pharmacology & Toxicology / Clinical Medicine / Neuroscience & Behavior

Research Subjects

• Research and development of production of radionuclides with clinical cyclotrons
• Development of automated chemical modules for noble radio-labeled probes
• Development of effective productions of radio-labeled probes under GMP.

Publications

1. K. Hayashi, A. Tachibana, S. Tazawa, Y. Mizukawa, K. Osaki, Y. Morimoto, R. Zochi, M. Kurahashi, H. Aki, K. Takahashi
   Preparation and stability of ethanol-free solution of [¹⁸F]florbetapir ([¹⁸F]AV-45) for positron emission tomography amyloid imaging.
   J. Labelled Compds. Radiopharm. Article first published online: 30 JAN 2013 DOI: 10.1002/jlcr.3021
2. Kyono K, Takashima T, Katayama Y, Kawasaki T, Zochi R, Gouda M, Kuwahara Y, Takahashi K, Wada Y, Onoe H, Watanabe Y
   [¹⁸F]FDOPA-PET for in vivo evaluation of dopaminergic dysfunction in unilaterally 6-OHDA-lesioned rats.
   Eur J Nucl Med Mol Imaging. 38, 589-94, 2011
3. Takashima-Hirano M, Tazawa S, Takahashi K, Doi H, Suzuki M
   Efficient synthesis of [¹¹C]ramelteon as a positron emission tomography probe for imaging melatonin receptors involved in circadian rhythms.
   Chem Pharm Bull. 59, 1062-4, 2011
4. Takashima T, Yokoyama C, Mizuma H, Yamanaka H, Wada Y, Onoe K, Nagata H, Tazawa S, Doi H, Takahashi K, Morita M, Kanai M, Shibasaki M, Kusuhara H, Sugiyama Y, Onoe H, Watanabe Y
   Developmental Changes in P-Glycoprotein Function in the Blood-Brain Barrier of Nonhuman Primates: PET Study with R-11C-Verapamil and 11C-Oseltamivir.
   J Nucl Med. 52, 950-7, 2011
5. Yamamoto S, Ohba H, Nishiyama S, Takahashi K, Tsukada H
   Validation of reference tissue model of PET ligand [¹¹C](+)3-MPB for the muscarinic cholinergic receptor in the living brain of conscious monkey.
   Synapse. 65, 548-51, 2011
6. S. Tazawa, K. Hasegawa, K. Takahashi, T. Yano, Y. Watanabe
   Current Practice of producing 64Cu-DOTA-Trastuzumab Injections RIKEN CMIS according to GMP for Investigational Products.
   PHARM TECH JAPAN, 27(4), 27-36, 2011.
7. S. Tazawa, K. Takahashi, T. Yano
   GMP Validation for PET Radiopharmaceuticals in RIKEN CMIS -Part 3-
   PHARM TECH JAPAN, 26 (10), 1883-1888, 2010.
8. K. Takahashi, S. Tazawa, T. Yano
   GMP Validation for PET Radiopharmaceuticals in RIKEN CMIS -Part 2-
   PHARM TECH JAPAN, 26 (8), 1405-1409, 2010.
9. T. Yano, S. Tazawa, K Takahashi
   GMP Validation for PET Radiopharmaceuticals in RIKEN CMIS -Part 1-
   PHARM TECH JAPAN, 26 (7), 1095-1100, 2010.