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Shunsuke Ono

Explore the profile of Shunsuke Ono including associated specialties, affiliations and a list of published articles. Areas
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Articles 64
Citations 274
Followers 0
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Recent Articles
1.
Mita S, Ono S
Clin Pharmacol Ther . 2025 Feb; PMID: 39996572
Drug dose appropriateness is one of the most discussed issues in regulatory reviews. We analyzed dose determinations during Food and Drug Administration (FDA) drug reviews to determine whether there were...
2.
Ishizuka K, Ono S
J Clin Pharmacol . 2024 Dec; PMID: 39654374
Despite the tremendous effort in the oncology community, the success rate of anticancer development remained low at 30% to 40% from the Phase 3 study to the regulatory approval. The...
3.
Wu C, Ono S
Ther Innov Regul Sci . 2024 Oct; 59(1):9-19. PMID: 39480630
We analyzed factors shaping the choice of the lead indication (i.e., cancer type) in the first clinical development projects of new oncological drugs in the United States (US), and how...
4.
Harada K, Ono S
Sci Rep . 2024 Mar; 14(1):7194. PMID: 38531888
Pharmaceutical companies have adopted biomarker-based enrichment (personalized) strategies to improve research and development productivity. We explored the background in which personalized strategies are adopted and examined whether their adoption is...
5.
Moriyama T, Yoritate M, Kato N, Saika A, Kusuhara W, Ono S, et al.
J Am Chem Soc . 2024 Jan; 146(3):2237-2247. PMID: 38196121
The acetal (-glycoside) bonds of glycans and glycoconjugates are chemically and biologically vulnerable, and therefore -glycosides are of interest as more stable analogs. We hypothesized that, if the -glycoside linkage...
6.
Ishida N, Ono S, Suzuki R, Nojiri K, Ootsuki S, Zakoji N
J Clin Neurosci . 2023 Jul; 115:71-76. PMID: 37499322
Drooling represents a common and noteworthy symptom in patients with intractable neuromuscular disease (IND) and cerebral palsy (CP) and can lead to poor quality of life (QOL) and higher incidence...
7.
Inui S, Takahashi Y, Ueda Y, Ohira S, Washio H, Ono S, et al.
Anticancer Res . 2023 Jun; 43(7):3079-3087. PMID: 37351970
Background/aim: Angiosarcoma of the scalp (AS) is a rare tumor that has often been treated by total scalp irradiation (TSI). TSI has technical and dosimetric challenges. This study aimed to...
8.
Teraoka A, Ono S, Ida R, Tsutani K
JMA J . 2022 Nov; 5(4):528-532. PMID: 36407074
We discuss the term "compassionate use" (CU) as an example of terminology having a huge impact on drug regulation. CU is used in many confusing situations, and its meaning varies...
9.
Sato Y, Ono S
Ther Innov Regul Sci . 2022 Sep; 57(2):227-237. PMID: 36112305
Background: This study aimed to demonstrate the differences in the way cell and gene therapy (CGT) products have been developed and reviewed for approval in Japan, the USA, and the...
10.
Ogawa H, Aoki M, Ono S, Watanabe Y, Yamamoto S, Tanaka K, et al.
Langmuir . 2022 Sep; 38(37):11432-11439. PMID: 36082480
We have succeeded in visualizing the spatial heterogeneity of the reaction ratio in epoxy resins by combining medium-angle X-ray scattering (MAXS) and computed tomography (CT). The reaction ratio is proportional...