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Therapeutic innovation & regulatory science.

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中文名称：治疗创新与监管科学。

ISSN：2168-4790
出版周期：Bimonthly

发文量：421

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1.Risk-Based Monitoring: Key Conditions in Collaboration Between Contract Research Organization and Sponsor

机译：基于风险的监测：合同研究组织与赞助商合作的关键条件
- 作者：Wolfs Marion;Bambic Amy;Spurden-de Lange Barbara;Galante Kristy;Sanchez Plaza Raquel;OConallain Crona;Racaro Graciela;Giblin Martin;Djali Sina
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
- risk-based monitoring;
- collaboration;
- sponsor;
- CRO;
- definitions;
- system capabilities;
2.Comparison of Postdoctoral Pharmacy Training Programs: Drug Information Residencies and Medical Information Fellowships

机译：博士后药房培训计划的比较：药物信息居民及医疗信息奖学金
- 作者：Gonzalez Jimmy;Bryant Samantha;Hogan Michael;Bai Sandra;Fierro Lesley;Hermes-DeSantis Evelyn R.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
- medical information;
- drug information;
- postgraduate pharmacy training;
- residency;
- fellowship;
3.Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

机译：治疗糖尿病的未来观点：监管框架的重要性
- 作者：Tsukamoto Katsura;Cnop Miriam;Mori Daichi;Kume Shoen;Anazawa Takayuki;Doi Masako;Chikazawa Kazuhiko;Matsumaru Naoki
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
- pharmacotherapy;
- pharmaceutical approval;
- regulatory guidance;
- type 1 diabetes mellitus;
- type 2 diabetes mellitus;
4.Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development

机译：质量风险管理框架：在临床发展中成功实施风险管理的指导
- 作者：Suprin Melissa;Chow Allan;Pillwein Marion;Rowe Jonathan;Ryan Martin;Rygiel-Zbikowska Beata;Wilson Kevin Joseph;Tomlin Irene
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第1期
- risk management;
- ICH E6(R2);
- quality management system;
- clinical trial risk assessment;
- quality risk management;
5.Cancer Clinical Trials: Treatment Costs Associated With a Spanish National Health System Institution

机译：癌症临床试验：与西班牙国家卫生系统机构相关的治疗费用
- 作者：Capdevila Ferran;Vera Ruth;Ochoa Patricia;Galbete Arkaitz;Sanchez-Iriso Eduardo
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
- cancer clinical trials;
- treatment costs;
- excess costs;
- cost savings;
- costs attribution;
6.A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways

机译：拟议的框架，用于全球适用的务实方法来使用促进的监管途径
- 作者：Liberti Lawrence;McAuslane Neil;Stolk Pieter;Breckenridge Alasdair;Leufkens Hubert
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
7.Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them

机译：提高药物开发和患者与合适的人，流程和文化：现在需要发生的事情，为需要他们的患者带来更好的药物
- 作者：Grignolo Alberto;Siu Albert
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第3期
- workforce training;
- diversity;
- virtual global organization;
- innovation;
- clinical trials;
- payers;
8.Role of Patients and Parents in Pediatric Drug Development

机译：患者和父母在儿科药物开发中的作用
- 作者：Tsang Vivian W. L.;West Leanne;Woods Christine;Koh Chester J.;McCune Susan;Mullin Theresa;Smith Sharon R.;Gaillard Segolene;Claverol Joana;Nafria Begonya;Preston Jennifer;Dicks Pamela;Thompson Charles
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
- pediatrics;
- youth;
- patient-oriented research;
- innovation;
- drug-development;
- clinical trials;
9.Development of a Computer-Assisted Adverse Drug Events Alarm and Assessment System for Hospital Inpatients in China

机译：发展计算机辅助不良药物事件报警和医院住院患者评估系统
- 作者：Chen Chao;Jia Wangping;Guo Daihong;Zhu Man;Xu Yuanjie;Wang Xiaoyu;Wang Dongxiao;Wang Weilan;Tang Zhihui
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- adverse drug events (ADEs);
- clinical pharmacists;
- computerized alarm;
- automatic screening;
- risk characteristics;
10.Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients

机译：与抗癫痫药物相关的唇裂和/或口感的风险：患者安全信号检测和评估呈递给处方和患者的信息
- 作者：Rezaallah Bita;Lewis David John;Zeilhofer Hans-Florian;Berg Britt-Isabelle
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第1期
11.What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI

机译：什么推动通过国家标签作为全球参考标签？与JPI进行案例研究
- 作者：Yoshida Shimon;Matsui Rie;Kikuchi Chikara
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第6期
- label;
- global reference;
- J-PI;
- Asia;
- CCDS;
12.Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives

机译：与美国和欧洲联盟相比，印度的药物观：挑战和观点
- 作者：Jobin Jose;Naziya Refi Rafeek
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第6期
13.Innovation and Opportunities in Pediatric Therapeutic Development

机译：儿科治疗发展的创新与机遇
- 作者：McCune Susan;Portman Ronald J.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
14.Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions

机译：索取医疗信息的客户调查：患者和医疗保健专业人员的偏好和信息需求，以支持治疗决策
- 作者：Fung Stacey M.;Sud Cheryl;Suchodolski Matthew
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- medical information services;
- information needs;
- patients;
- health care professionals;
15.Improving Clinical Trial Participant Prescreening With Artificial Intelligence (AI): A Comparison of the Results of AI-Assisted vs Standard Methods in 3 Oncology Trials

机译：用人工智能提高临床试验参与者（AI）：3次肿瘤学试验中AI辅助与标准方法的结果进行比较
- 作者：Calaprice-Whitty Denise;Galil Karim;Salloum Wael;Zariv Ashkon;Jimenez Bernal
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
16.A Practical Perspective: Application of the Generalized Approach for Adaptive Design

机译：一种实用的视角：适用于自适应设计的广义方法
- 作者：Wang Jin;Li Juanjuan;Shu Yu;Su Xiaolu
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- adaptive;
- conditional power;
- Finkelstein-Schoenfeld;
- Anderson-Gill;
17.Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

机译：监管/科学支持MICL，中小型企业（中小型企业（中小企业），由PMDA和EMA提供的药品
- 作者：Kondo Hideyuki;Shibatsuji Masayoshi;Yasuda Naoyuki
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第2期
- SME;
- PMDA;
- EMA;
- product development;
18.Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development

机译：测量患者参与和患者中心的影响在临床研究与发展中
- 作者：Stergiopoulos Stella;Michaels Debra L.;Kunz Barbara Lopez;Getz Kenneth A.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- patient engagement;
- patient centricity;
- patient-centric initiatives;
- clinical trial design;
- return on investment;
- return on engagement;
19.Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms

机译：评估法律立法的合规性和临床试验可读性知情同意书
- 作者：Gungor Buket;Aylin Mualla;Asena Ayse;Somuncuoglu Elif Inci;Bozkurt Nihan Burul;Ucku Serife Reyhan;Gelal Ayse
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- human subjects;
- health literacy;
- ethics committee;
- Atesman formula;
- consent document;
20.Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption

机译：跨利益相关者群体的意识和合作对于实现价值驱动的收养来说很重要
- 作者：Hilde Vanaken;Shirley N. Masand
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第6期
- TransCelerate;
- eConsent;
- Electronic Informed Consent;
- Clinical Research;
- Digital;
- Patient-Centric;
21.Evaluating the Completeness of ClinicalTrials.gov

机译：评估ClincoricTrials.gov的完整性
- 作者：Stergiopoulos Stella;Getz Kenneth A.;Blazynski Christine
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第3期
22.Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions

机译：基于风险的监测（RBM）实施：挑战和潜在解决方案
- 作者：Limaye Nimita;Jaguste Veena
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第2期
- clinical trials;
- protocol design;
- QbD;
- central monitor;
- KRIs;
23.Measuring Blood Pressure in Clinical Practice We Can and Must Do Better

机译：测量临床实践中的血压，我们可以，必须做得更好
- 作者：Turner J. Rick
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第6期
24.The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies

机译：在临床研究中使用现实世界的证据和数据和批准安全研究
- 作者：Lamberti Mary Jo;Kubick Wayne;Awatin Josephine;McCormick John;Carroll James;Getz Ken
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第6期
- real-world evidence;
- real-world data;
- postapproval;
- safety assessments;
- postmarketing studies;
- wearables;
- social media;
25.Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

机译：全球监管景观为总安全评估：最近的发展和未来方向
- 作者：Ball Greg;Kurek Raffael;Hendrickson Barbara A.;Buchanan James;Wang William W.;Duke Susan P.;Bhattacharyya Amit;Li Mengchun;OBrien Dennis;Weigel Judith;Wang Wenquan;Jiang Qi;Ahmad Faiz;Seltzer Jonathan H.;Herrero-Martinez Esteban;Tremmel Lothar
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- interdisciplinary safety evaluation;
- aggregate safety assessment;
- medical judgment;
- SUSAR;
- RSI;
26.Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks

机译：评估REMS负担：3个渠道的比较时间分析，为REMS利益相关者执行强制性REMS任务
- 作者：Chapman Jennifer;Freeman John;Hechavarria Jorge;Dodeja Pritam;Sheehan Paul
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- ETASU;
- Pomalyst REMS;
- Revlimid REMS;
- Risk management;
- Thalomid REMS;
27.Statistical Practices of Safety Monitoring: An Industry Survey

机译：安全监测统计实践：行业调查
- 作者：Colopy Michael W.;Gordon Robert;Ahmad Faiz;Wang William W.;Duke Susan P.;Ball Greg
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第3期
- safety monitoring;
- regulatory guidance;
- interviews;
- survey;
- biostatistician;
28.Tiny and Forgotten: A Call for Focused Neonatal Policy Reform

机译：小而忘记：呼吁聚焦新生儿政策改革
- 作者：Bucci-Rechtweg Christina M.;Ward Robert M.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
- neonates;
- term infants;
- preterm infants;
- policy;
- policy reform;
- drug development;
29.Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective

机译：日本健康技术评估：制药业视角
- 作者：Kido Kaori;Matsumaru Naoki;Tsukamoto Katsura
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
- HTA;
- pharmaceutical pricing;
- health policy;
- industry survey;
- real world data;
30.Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement Directive

机译：采购医疗设备的投标：适应成本效益规则，以欧洲公共采购指令的要求
- 作者：Messori Andrea;Trippoli Sabrina;Caccese Erminia;Marinai Claudio
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- tender;
- medical devices;
- health economics;
- incremental cost-effectiveness ratio;
- net monetary benefit;
31.Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

机译：生物材料评价：概念改进和实际改革
- 作者：Masaeli Reza;Zandsalimi Kavosh;Tayebi Lobat
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第1期
- biomaterials evaluation;
- safety;
- performance;
- premarket evaluation;
- postmarket surveillance;
32.Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information

机译：透明医疗信息（PHACTMI）基准研究的制药合作：趋势，驾驶员，成功因素和医疗信息全球化的价值
- 作者：Giffin Suzana A.;Shah Richa;Soloff Allison;Vaysman Anna Markel;Oreper Jane;Gazo Andrew;Gandhi Pooja;Shah Ina;Malieckal Thomas;Boulos Daniel;Flowers Teresa;Stevens Carolle A.;Rocco Michael S.;Patel Aarti S.;Albano Dominick
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第3期
- medical information;
- globalization;
- benchmark study;
- technology;
- call centers;
33.Assessing Treatment Effects That Capture Disease Burden in Serious Chronic Diseases

机译：评估捕获严重慢性病疾病负担的治疗效果
- 作者：Akacha Mouna;Binkowitz Bruce;Claggett Brian;Hung H. M. James;Mueller-Velten Guenther;Stockbridge Norman
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第3期
- heart failure;
- time-to-first event;
- recurrent event endpoints;
- disease burden;
- terminal event;
- estimands;
34.Building Trust in RWE Will Support Clearer Regulatory Uses

机译：建立RWE的信任将支持更清晰的监管用途
- 作者：Daniel Gregory W.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
35.The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream

机译：个人级益处风险评估在治疗决策中的潜在作用：DIA研究终点社区工作流程
- 作者：Reaney Matthew;Bush Elizabeth;New Mary;Paty Jean;de Climens Aude Roborel;Skovlund Soren E.;Nelsen Linda;Flood Emuella;Gater Adam
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
- benefit-risk;
- patient preference;
- patient-reported outcomes;
- clinical outcome assessments;
- patient-centricity;
36.Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety

机译：临床研究外部设计，除了群体顺序试验外，还可以评估短期和长期疗效
- 作者：Yuan Jiacheng;Mesenbrink Peter;Zhou Jihao;Liu Jeen;Zhu Ray;Koch Gary
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第6期
- alpha spending function;
- graphical testing procedure;
- group sequential test;
- head-to-head design;
- safety assessment;
37.Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

机译：将估算与临床试验中的估算值对准：将ICH E9（R1）指引付诸实践
- 作者：Mallinckrodt C. H.;Bell J.;Liu G.;Ratitch B.;OKelly M.;Lipkovich I;Singh P.;Xu L.;Molenberghs G.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- estimands;
- estimation;
- missing data;
- sensitivity;
38.Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

机译：全面的体外预血淋力测定（CIPA）从心脏安全研究联盟/健康和环境科学研究所/ FDA会议上更新
- 作者：Strauss David G.;Gintant Gary;Li Zhihua;Wu Wendy;Blinova Ksenia;Vicente Jose;Turner J. Rick;Sager Philip T.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第4期
39.An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia

机译：出口到坦桑尼亚，尼泊尔和柬埔寨的药物登记要求概述
- 作者：Shelke Triveni V.;Khante Shyam;Sarda Mukund B.;Mahadik Kakasaheb R.;Gaikwad Vinod L.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第1期
- dossier;
- Tanzania;
- Nepal;
- Cambodia;
- Common Technical Document;
- ASEAN-CTD;
40.Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017

机译：2009年至2017年韩国与日本的药物滞后的显着差异
- 作者：Lee Sang-Won;Park So-Hee;Song Inmyung;Noh Yunha;Park Hyekyung;Ha Dongmun;Shin Ju-Young
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- drug lag;
- median approval lag;
- drug access;
- new drug;
- drug approval;
- drug;
41.Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

机译：采用分散式临床试验时的法律，监管和实际问题：临床试验转型倡议的建议
- 作者：Apostolaros Maria;Babaian David;Corneli Amy;Forrest Annemarie;Hamre Gerrit;Hewett Jan;Podolsky Laura;Popat Vaishali;Randall Penny
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第4期
- Mobile clinical trials;
- Mobile technology;
- Mobile medical applications;
- Mobile nursing;
- Participant-centric trials;
- Telehealth;
42.Peptide Phage Display: Molecular Principles and Biomedical Applications

机译：肽噬菌体展示：分子原理和生物医学应用
- 作者：Zambrano-Mila Marlon S.;Blacio Karen Elizabeth Sanchez;Vispo Nelson Santiago
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- phage display;
- peptide libraries;
- cancer;
- infection diseases;
- drug delivery system;
- clinical trials;
43.Disease Modification in Alzheimer's Disease: Current Thinking

机译：阿尔茨海默病的疾病修饰：目前的思维
- 作者：Liu-Seifert Hong;Schumi Jennifer;Miao Xiaopeng;Tian Ying;Rabbia Michael;Andersen Scott W.;Wilson Steve;Li Wen;Entsuah Richard
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2020年第2期
- Alzheimer's disease;
- disease modification;
- delayed start;
- persistent effect;
- biomarker;
- regulatory guidance;
44.Statistical Considerations for Bias and Protocol Deviation in Medical Device Pivotal Clinical Study

机译：医疗器械枢转临床研究中偏置和协议偏差的统计考虑因素
- 作者：Xu Zhiheng;Li Meijuan
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第5期
- clinical trial;
- clinical study;
- bias;
- protocol deviation;
- enrichment;
- statistical analysis plan;
45.Influence of Drug Lag on New Drug Label Revisions

机译：药物滞后对新药标签修订的影响
- 作者：Kikuchi Chikara;Murakami Miyako;Shimomura Hitoshi;Shimada Shuji;Aoyama Takao
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2019年第1期
- package insert;
- labeling;
- label revision;
- drug lag;
- postmarketing safety;
46.DIA Then and Now: A Half-Century Odyssey

机译：直到目的，现在：半个世纪的奥德赛
- 作者：Turner J. Rick
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
47.Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology Landscape

机译：优化临床试验中的电子数据源的使用：技术景观
- 作者：Kellar Ed;Bornstein Susan;Caban Aleny;Crouthamel Michelle;Celingant Catherine;McIntire Patricia A.;Johnson Chrissy;Mehta Prasann;Sikirica Vanja;Wilson Brett
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- TransCelerate;
- eSource;
- direct data capture;
- electronic data capture (EDC);
- electronic health record (EHR);
48.Quantitative Assessment of Premium Rates for Clinical Usefulness in New Drug Price Calculation in Japan

机译：日本新药品价格计算临床有用率的优质评估
- 作者：Takayama Akane;Kobayashi Eriko;Nakamura Tetsuya;Narukawa Mamoru
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- reimbursement;
- drug price;
- National Health Insurance (NHI);
- Health Technology Assessment (HTA);
- Japan;
49.Improving Investigative Site Contact Options on Clinical Trial Registries:: Making It Easier for Patients to Find Clinical Trials

机译：改善临床试验登记处的调查遗址联系方式::患者更容易找到临床试验
- 作者：Polidori Christa Patterson;Su Mandy S.;Jakee Kelsey;Hodge Keir;Ancona Crystal;Yoder Joseph
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- transcelerate;
- access;
- clinicaltrials;
- gov;
- surveys;
- respondents;
- advisory boards;
50.Drugs Targeted for Price Cutting in Japan: The Case of Price Revisions Based on the Divergence of Official Versus Delivery Prices

机译：针对日本价格切割的药物：根据官方与送货价格分歧的价格修订的情况
- 作者：Fukumoto Daigo;Tsuyuki Ai;Suzuki Takeshi
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- drug price revision;
- delivery price;
- Japan;
- generic;
- price cutting;
51.Analysis of Review Times for Recent 505(b)(2) Applications

机译：近505（b）（2）申请的审查时间分析
- 作者：Sakai Sharon;DiMasi Joseph A.;Getz Kenneth A.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- FDA;
- 505(b)(2);
- NDA review;
52.Improving Patient Involvement in Medicines Research and Development:: A Practical Roadmap

机译：改善患者参与药物研究和发展::实用的路线图
- 作者：Geissler Jan;Ryll Bettina;di Priolo Susanna Leto;Uhlenhopp Mary
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- patient involvement roadmap;
- patient input;
53.Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural Change

机译：全球临床调查员景观对结构变化的基线评估
- 作者：Getz Kenneth;Brown Carrie;Stergiopoulos Stella;Beltre Cerdi
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
54.Comparison of New Drug Accessibility and Price Between Japan and Major European Countries

机译：日本和主要欧洲国家新药物可访问性和价格的比较
- 作者：Takayama Akane;Narukawa Mamoru
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
55.On a Stepwise Quantitative Approach for Benefit-Risk Assessment

机译：关于受益风险评估的逐步定量方法
- 作者：He Weili;Sun Yaxuan;Li Qing;Wan Sabrina
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- benefit-risk assessment;
- standardized scores;
- probability of technical success;
- framework;
- joint evaluation;
- benefit-risk trade-offs;
56.Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan

机译：对日本未经批准的抗癌药物的调查征领的调查新药物试验的影响因素调查
- 作者：Sudo Tomohisa;Sato Akihiro
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- risk-based monitoring;
- RBM;
- data quality;
- clinical trial;
- investigator-initiated IND trial;
57.Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient Medicines

机译：进口测试：过时的练习？改进安全和高效药物的机会
- 作者：Garbe Joerg H. O.;Jacobs Maria G.;Ronninger Stephan K.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
58.Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry

机译：通过临床试验参与者改进信息交流：行业提案
- 作者：Dietrich Julie;Alivojvodic Jeannine;Seliverstov Irene;Metcalf Marilyn;Jakee Kelsey
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- TransCelerate;
- clinical research;
- patient engagement;
- drug development;
- health care;
59.The Case for a Bayesian Approach to Benefit-Risk Assessment:: Overview and Future Directions

机译：贝叶斯方面受益风险评估的案例::概述和未来方向
- 作者：Costa Maria J.;He Weili;Jemiai Yannis;Zhao Yueqin;Di Casoli Carl
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- benefit-risk;
- Bayesian inference;
- decision-making;
- uncertainty;
60.Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification

机译：在新模块1规范中提交促销2253提交的最佳实践
- 作者：Krogulski Sandra
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
- advertising;
- promotional;
- Module 1;
- FDA;
- eCTD;
61.The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory Authorities

机译：药物的效益风险评估：中型监管机构联盟的经验
- 作者：McAuslane Neil;Leong James;Liberti Lawrence;Walker Stuart
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第5期
62.Impact of Expanded Access on FDA Regulatory Action and Product Labeling

机译：扩大访问对FDA监管行动和产品标签的影响
- 作者：Jarow Jonathan P.;Moscicki Richard
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- expanded access;
- new drug application;
- drug development;
- compassionate use;
63.Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars

机译：建立生物仿制物中药代动力学和疗效等效的自适应无缝设计
- 作者：Uozumi Ryuji;Hamada Chikuma
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- adaptive seamless PK and efficacy design;
- biosimilar infliximab;
- clinical trials;
- sample size recalculation;
64.Implications of CRISPR-Based Germline Engineering for Cancer Survivors

机译：基于CRISPR的种系工程对癌症幸存者的影响
- 作者：Katz Gregory;Pitts Peter J.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- CRISPR;
- germline;
- eugenics;
- cancer survivor;
- economic burden;
65.Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health

机译：优化的医疗产品监管在墨西哥：公共和经济健康的双赢
- 作者：Arriola Penalosa Mikel Andoni;Cavazos Cepeda Ricardo;Alanis Garza Mario;Lumpkin Murray M.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
66.Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments

机译：使用定性数据来支持基于性能的认知结果评估的内容有效性
- 作者：Edgar Chris J.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
67.An Innovative, Collaborative, and Strategic Approach to Proactively Evaluate and Update Drug Interactions Based on Prescribing Information of Newly Approved Medicinal Products

机译：基于新批准的药品的处方信息，积极评估和更新药物相互作用的创新，协作和战略方法
- 作者：Porcalla Ariel;Barshteyn Nella;Snyder Scott;Bhattacharya Mondira
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- drug-drug interaction;
- evidence-based medicine technology platform;
- algorithm;
- CYP3A4;
- prescribing information;
68.The Common Pharmaceutical Market of the Eurasian Economic Union: A Regulatory Review

机译：欧亚经济联盟的普通药物市场：监管审查
- 作者：Lozda Raimond
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
69.Dose Finding in Late-Phase Drug Development

机译：晚期药物开发中的剂量发现
- 作者：Nie Lei;Lee Kyung Y.;Verdun Nicole;De Claro R. Angelo;Sridhara Rajeshwari
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- dose-response;
- dose-toxicity;
- Bayesian design;
- marginal structure model;
70.Bone Mineral Density to Assess Pediatric Bone Health in Drug Development

机译：骨矿物质密度评估药物开发中的儿科骨骼健康
- 作者：Maas Brian M.;Wang Jian;Cooner Freda;Green Dionna;Yuan Ye;Yao Lynne;Burckart Gilbert J.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- bone mineral density;
- inhaled corticosteroids;
- pediatric growth;
- drug development;
71.Assessing Recall and Recognition for Important Safety Information in Digital Promotion for Pharmaceutical Products: Implications for Website Design

机译：评估药品数字促进的重要安全信息的回忆和认识：网站设计的影响
- 作者：Polster Michael;Thumma Clifford;Trainer Pamela C.;Pearson Kathleen;Dianno Nicole;Kumar Nisith
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- direct-to-consumer advertising;
- digital media;
- regulatory policy;
72.Update From the Field of Renal Sympathetic Denervation: A Focus on Safety Nomenclature Considerations

机译：从肾交感神经剥夺领域的更新：专注于安全命名的考虑
- 作者：Turner J. Rick
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
73.Editorial Board Member's Commentary: Commissioner Scott Gottlieb's Predictable Imaginarium

机译：编辑委员会成员的评论：斯科特·斯科特利亚专员可预测的富有想象力
- 作者：Pitts Peter J.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
74.Reference Limits for Outlier Analyses in Randomized Clinical Trials

机译：随机临床试验中的异常分析参考限制
- 作者：Beasley Charles M. Jr.;Crowe Brenda;Nilsson Mary;Wu LieLing;Tabbey Rebeka;Hietpas Ryan T.;Dean Robert;Horn Paul S.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2017年第6期
- reference limits;
- nonparametric method;
- robust method;
- outliers;
75.Adverse Reactions to Radiopharmaceuticals: A Survey Based on Clinical Cases Using Criteria of Systematic Review

机译：对放射性药物的不良反应：基于临床病例的调查，使用系统审查标准
- 作者：Pinto Suyene Rocha;Cavalcanti Santos Luis Filipe;Rezende dos Reis Sara Rhaissa;Bastos Matheus Keuper;Gomes Vitoria da Silva;Vieira Thamires de Oliveira;Santos-Oliveira Ralph
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- radiopharmaceuticals;
- adverse reaction;
- drug interaction;
- adverse effects;
76.Evolution of Drug Development: Integrating the Patient Perspective Into Early Research

机译：药物发展的演变：将患者视角整合到早期研究
- 作者：Yanni Anthony J.;Fine Jennifer
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- patient perspective;
- unmet need;
- medical value;
- risk/opportunity assessment;
- medical intelligence;
77.Principles and Methods of Statistical Assessment of Abuse-Deterrent Opioids

机译：滥用禁险阿片类药物统计评估的原则和方法
- 作者：Chen Ling
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
78.Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac

机译：澳大利亚和英国的比较用户测试Diclofenac的柜台上的柜台和传单
- 作者：Tong Vivien;Raynor David K.;Aslani Parisa
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- user testing;
- nonprescription drugs;
- drug labeling;
- medication safety;
- consumers;
79.A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan

机译：医疗器械规范的比较研究：美国，欧洲，加拿大和台湾
- 作者：Chen Yi-Jung;Chiou Chi-Ming;Huang Yu-Wen;Tu Pei-Weng;Lee Yung-Chuan;Chien Chia-Hung
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- safety;
- effectiveness;
- regulatory reform;
- IMDRF;
- harmonization;
80.Neonatal Safety Information Reported to the FDA During Drug Development Studies

机译：在毒品开发研究期间向FDA报告的新生儿安全信息
- 作者：Avant Debbie;Baer Gerri;Moore Jason;Zheng Panli;Sorbello Alfred;Ariagno Ron;Yao Lynne;Burckart Gilbert J.;Wang Jian
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- neonates;
- serious adverse events;
- drug development;
- safety;
- US FDA;
81.Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information Processing

机译：处方药信息传单的发展：认知努力和患者对处方药物信息处理的影响
- 作者：Patel Harshali K.;Bapat Shweta S.;Bhansali Archita H.;Sansgiry Sujit S.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- prescription drug information leaflet;
- information processing;
- comprehension;
- cognitive effort;
82.Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report

机译：对儿童参与临床试验的行业和患者观点：儿科同意倡议调查报告
- 作者：Lombardi Donald;Squires Liza;Sjostedt Philip;Eichler Irmgard;Turner Mark A.;Thompson Charles
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- pediatrics;
- pediatric assent;
- clinical trials;
- consent;
- survey;
83.Medical Writing Competency Model - Section 2: Knowledge, Skills, Abilities, and Behaviors

机译：医学写作能力模型 - 第2节：知识，技能，能力和行为
- 作者：Clemow David B.;Wagner Bertil;Marshallsay Christopher;Benau Dan;LHeureux Darryl;Brown David H.;Dasgupta Devjani Ghosh;Girten Eileen;Hubbard Frank;Gawrylewski Helle-Mai;Ebina Hiroko;Stoltenborg Janet;York J. P.;Green Kim;Wood Linda Fossati;Toth Lisa;Mihm Michael;Katz Nancy R.;Vasconcelos Nina-Maria;Sakiyama Norihisa;Whitsell Robin;Gopalakrishnan Shobha;Bairnsfather Susan;Wanderer Tatyana;Schindler Thomas M.;Mikyas Yeshi;Aoyama Yumiko
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- medical;
- writing;
- competency;
- regulatory;
- publication;
84.Cardiodiabesity and Related Updates

机译：心碘和相关更新
- 作者：Turner J. Rick
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
85.Statistical Interactions in a Clinical Trial

机译：临床试验中的统计学相互作用
- 作者：Ting Naitee
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- statistical interaction;
- subgroup analysis;
- analysis of covariance;
- multiregional clinical trial;
- confirm and explore;
86.Medical Science Liaisons in Real-World Evidence Studies: Experience of AstraZeneca Russia

机译：实际证据研究中的医学科学辽泻：Astazeneca俄罗斯的经验
- 作者：Suvorov Nikolay;Karaseva Vera;Stukalina Ekaterina;Sanay Elkhan;Petrakovskaya Vera;Bulatov Vladimir
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- real-world evidence;
- non-interventional studies;
- enrollment rate;
- communication;
- medical science liaison;
87.Medical Writing Competency Model - Section 1: Functions, Tasks, and Activities

机译：医学写作能力模型 - 第1节：职能，任务和活动
- 作者：Clemow David B.;Wagner Bertil;Marshallsay Christopher;Benau Dan;LHeureux Darryl;Brown David H.;Dasgupta Devjani Ghosh;Girten Eileen;Hubbard Frank;Gawrylewski Helle-Mai;Ebina Hiroko;Stoltenborg Janet;York J. P.;Green Kim;Wood Linda Fossati;Toth Lisa;Mihm Michael;Katz Nancy R.;Vasconcelos Nina-Maria;Sakiyama Norihisa;Whitsell Robin;Gopalakrishnan Shobha;Bairnsfather Susan;Wanderer Tatyana;Schindler Thomas M.;Mikyas Yeshi;Aoyama Yumiko
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- medical;
- writing;
- competency;
- regulatory;
- publication;
88.Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements

机译：风险评估与直接消费者（DTC）处方药电视广告中的益处信息
- 作者：Fahim Germin;Toscani Michael;Barone Joseph A.;Wang Chris;Gandhi Shivani
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- direct-to-consumer;
- advertising;
- pharmaceutical advertising;
- television;
- prescriptions;
89.New Benchmarks Characterizing Growth in Protocol Design Complexity

机译：新的基准表征协议设计复杂性的增长
- 作者：Getz Kenneth A.;Campo Rafael A.
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
90.Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries

机译：美国儿科药物发展的行业视角：欧盟国家的参与
- 作者：Onishi Taku;Tsukamoto Katsura;Matsumaru Naoki;Waki Takashi
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- pediatric pharmacotherapy;
- therapeutic orphan;
- pharmaceutical industry;
- regulatory framework;
- incentive;
91.Pharmacotherapeutic Reports as Tools for Detecting Discrepancies in Continuity of Care

机译：药物治疗报告作为用于检测关注连续性差异的工具
- 作者：Yaiza Romero-Ventosa Elena;Gayoso-Rey Monica;Samartin-Ucha Marisol;Lamas-Dominguez Pablo;Rubianes-Gonzalez Martin;Rodriguez-Lorenzo David;Holanda Rodriguez-Vazquez Maria;Garcia-Comesana Julio;Pineiro-Corrales Guadalupe
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第1期
- primary care;
- specialized care;
- continuity of care;
- care levels;
- pharmaceuticals;
92.Reporting of Randomized Clinical Trials Remains Far from Optimal

机译：随机临床试验的报告仍然远非最佳
- 作者：J. Rick Turner
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
93.Sources of Safety Data and Statistical Strategies for Design and Analysis

机译：安全数据来源和设计和分析的统计策略
- 作者：Richard C. Zink;Olga Marchenko;Matilde Sanchez-Kam;Haijun Ma;Qi Jiang
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- adverse events;
- data monitoring committee;
- data visualization;
- multiplicity;
- meta-analysis;
- subgroup analysis;
94.Patient Drug Safety Reporting

机译：病人药物安全报告
- 作者：Puja Patel;David Spears;Betina ?stergaard Eriksen;Karsten Lollike;Michael Sacco
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- drug safety department;
- patient reporting;
- adverse events;
95.Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis

机译：介绍安全数据来源和设计和分析统计策略的特殊部分
- 作者：Richard C. Zink
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
96.Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine

机译：外推儿科药物开发与循证医学的疗效
- 作者：Haihao Sun;Jean W. Temeck;Wiley Chambers;Ginger Perkins;Renan Bonnel;Dianne Murphy
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- Pediatric Efficacy Trial;
- Extrapolation of Efficacy;
- Drug Development;
97.The Rules of Engagement

机译：订婚规则
- 作者：Diane Bloom;Joel Beetsch;Matthew Harker;Sharon Hesterlee;Paulo Moreira;Bray Patrick-Lake;Wendy Selig;Jeffrey Sherman;Sophia K. Smith;James E. Valentine;Jamie N. Roberts
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- patient group engagement;
- actionable recommendations;
- clinical trials;
- therapeutic development;
- best practices;
98.Sources of Safety Data and Statistical Strategies for Design and Analysis

机译：安全数据来源和设计和分析的统计策略
- 作者：Olga Marchenko;Estelle Russek-Cohen;Mark Levenson;Richard C. Zink;Michelle R. Krukas-Hampel;Qi Jiang
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- adverse events;
- safety assessment;
- EHR/EMR;
- pragmatic trial;
- observational study;
- registry;
99.Assessing the Financial Value of Patient Engagement

机译：评估患者参与的财务价值
- 作者：Bennett Levitan;Kenneth Getz;Eric L. Eisenstein;Michelle Goldberg;Matthew Harker;Sharon Hesterlee;Bray Patrick-Lake;Jamie N. Roberts;Joseph DiMasi
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- patient engagement;
- therapeutic development;
- expected net present value;
- risk-adjusted financial model;
100.Use of Proprietary Names by Prescribers for Generic Products

机译：使用专有名称的专有名称的仿制产品
- 作者：Vicky Borders-Hemphill;Irene Z. Chan;Katelyn Brown;Briana Rider;Kellie Taylor;Grace Chai
- 期刊名称：《Therapeutic innovation & regulatory science.》 | 2018年第2期
- prescribing practice;
- proprietary name;
- generic;
- drug name confusion;
- branded-generic;
- medication error;

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