Shingo Niimi

[Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo].

Shingo Niimi, Mitsuo Umezu, Hiroshi Iseki, 2014, Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo hokoku = Bulletin of National Institute of Health Sciences.

1A31 Development of guidance documents for the approval process of innovative joint prostheses

Shingo Niimi, Hideyuki Sakoda, 2015 .

1B42 Development of a pulsatile flow simulator for the assessment of proper deployment of fenestrated stent grafts

Mitsuo Umezu, Shingo Niimi, Ryusuke Nakaoka, 2015 .

2F13 Development of a registration method using points of skeleton for navigation in blood vessel prosthesis replacement and error assessment using clinical data

Shingo Niimi, Mitsuo Umezu, Hiroshi Iseki, 2016 .

2B25 Establishment of Non-clinical In Vitro Testing System and Methodology of Innovative Medical Devices for Approval : Facilitating Engineering Based Medicine

Shingo Niimi, Mitsuo Umezu, Hiroshi Iseki, 2016 .

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

Shingo Niimi, 2015, Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo hokoku = Bulletin of National Institute of Health Sciences.

Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays.

Shingo Niimi, Akiko Ishii-Watabe, Noriko Katori, 2015, Bioanalysis.

Spheroid formation and expression of liver-specific functions of human hepatocellular carcinoma-derived FLC-4 cells cultured in lactose-silk fibroin conjugate sponges.

Shingo Niimi, T. Matsuura, Yohko Gotoh, 2011, Biomacromolecules.

Preparation of lactose-silk fibroin conjugates and their application as a scaffold for hepatocyte attachment.

Shingo Niimi, Takao Hayakawa, Tokuji Miyashita, 2004, Biomaterials.

Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study.

Shingo Niimi, Akiko Ishii-Watabe, Hiroko Shibata, 2019, Bioanalysis.