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CMIC：2022年真实世界数据：在日本实现患者处方旅程的数字化报告（英文版）

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2025-08-02 48 2.24MB 5页
CMIC：2022年现实世界数据如何革新罕见肿瘤药物开发报告（英文版）

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2025-08-02 31 324.38KB 7页
CMIC：2021年今日日本的临床研究报告：后疫情时代，重新审视世界第二大处方药市场（英文版）

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2025-08-02 50 5.36MB 7页
CMIC：2019年在药物开发新时代中定制生物分析测试报告（英文版）

All of this again favors strategic partnerships with specialist service providers, basedless on size than on flexible and responsive expertise. “Client needs are changing inthat respect," Suga comments.“Our clients tend to be relatively entrepre...

2025-08-01 40 5.39MB 9页
CMIC：2012年全球生物分析委员会（GCC）对新欧洲药品管理局生物分析方法验证指南的解释建议白皮书（英文版）

Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA)...

2025-08-01 36 3.96MB 10页
CMIC：2011年关于内部标准准则、稳定性、已发生的样品重新分析和全球生物分析合同研究组织委员会最近的483s的建议报告（英文版）

During the 2nd Closed Forum, it was reiterated that the GCC is unique since it is the companies that are members rather than individuals and each is equal within the organization (i.e., there is no hierarchical structure). In an effort to accommodate...

2025-08-01 119 2.13MB 10页
CMIC：2021年亚洲之门：日本和韩国的市场准入白皮书（英文版）

asia offers rich opportunities forpharmaceutical companies seekingalternatives to the mature markets inNorth America or Europe. Two essentialpillars of the region are japan and South Korea.Both have been progressively opening up to theglobalization o...

2025-08-01 29 2.21MB 9页
CMIC：2020年数字疗法的兴起：构建未来报告（英文版）

Digital therapeutics (DTx) are evolving rapidly. any now provide drug-like mechanisms of action thatdeliver greater value to both standalone solutions and therapies that pair DTx with prescription drugsTo succeed in the market, companies must attract...

2025-08-01 28 258.16KB 8页
CMIC：2020年在不确定时期管理制造报告（英文版）

Virtual pharmaceutical companies often have strong regulatory and clinical teams, but often they lackthe resources needed to address the complexities of the complete product development and com-mercialization cycle. Partnering with a contract develop...

2025-08-01 28 222.9KB 7页
CMIC：2020年快速变化的研发流程如何放大可适应的CRO的重要性白皮书（英文版）

Major advances in our understanding of the causes of once-untreatable diseases have reshaped the global drug development pipeline over the past decade, paving the way for better health outcomes for many millions of people. To realize these emerging o...

2025-08-01 31 1.1MB 9页
CMIC：C-PRESS公共关系杂志-第16卷（英文版）

Nakamura Since the end of the Second World War, the average lifetime has increased rapidly in Japan and the Japanese have the longest life expectancy in the world. Establishment of world-class, excellent systems, such as a universal health insurance ...

2025-08-01 23 9.34MB 7页
CMIC：2020年强化的CMO关系为赞助商扩展机会报告（英文版）

Key strategies that can lead to a win-win relationship include a relationshipon a solid foundation, softfactors, and project managementexcellence. This article discussesthese strategies as well as FDAguidelines on quality agreementsfor the contract m...

2025-08-01 23 4.66MB 30页
CMIC：2020年早期药物开发报告（英文版）

While pivotal clinical trials remain critical to securing the approvalsrequired for the launch of new drugs, it is interesting and also encouraging to observe acommon thread running through some recent regulatory and policy discussions.That theme is ...

2025-08-01 25 5.87MB 18页
CMIC：2013年全球合同研究组织委员会（GCC）关于已使用样品稳定性（ISS）的建议白皮书（英文版）

The topic of Incurred Sample Stability (lSS) has generated considerable discussion within thebioanalytical community in recent years. The subject was an integral part of the 7" annualWorkshop on Recent lssues in Bioanalysis (WRlB) held in Long B...

2025-08-01 33 5.13MB 11页
CMIC：2011年GCC关于生物分析方法稳定性对联合给药和联合配方药物影响的建议白皮书（英文版）

In 2010, the global bioanalytical community learned of regulatory agency concern of the potential for co-administered compounds present in a bioanalytical matrix to impact the stability of analytes subject to bioanalytical measurement. This pertained...

2025-08-01 23 612.63KB 11页
CMIC：2019年亚洲临床试验报告（英文版）

there is no longer any excuse not toinclude japan as an integral part of anyglobal clinical-development programfor either pharmaceuticals or medicaldevices. With a more receptive climatefor both starting and running trials, an improvedinfrastructure ...

2025-08-01 34 2.45MB 20页
CMIC：2017年全球临床试验的变革之面：亚太地区成为专业生物制药的理想目的地白皮书（英文版）

The contract research organization (CRO) marketin the Asia-Pacific (APAC) region is the fastest-growing in the world, with revenue expected toincrease at a 20% compound annual growth rate(CAGR) from 2016 to 202l compared with therest of the world'...

2025-08-01 30 1.49MB 32页
CMIC：2018年如何在日本成功进行临床试验白皮书（英文版）

There is no longer any excuse not to include Japan as an integral part of any globalclinical-development program for either pharmaceuticals or medical devices. With amore receptive climate for both starting and running trials, an improved infrastruct...

2025-08-01 36 227.32KB 9页
CMIC：2019年药物开发与制造：挑战与机遇报告（英文版）

QUESTION :In 2007, CMIc acquired a manufacturingplant in New Jersey. That early acquisition became CMICCMO USA, a contract service provider for oral solid drugmanufacturing. What has changed for the Us part of thecompany?MAKOTO MATSUKAWA: The origina...

2025-08-01 25 877.8KB 15页
水井坊：2021年环境、社会、公司治理（ESG）报告（英文版）

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2025-07-31 41 8.49MB 57页

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