Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implications [0.03%]
制药业中的药物再配方和重新定位及其对市场准入的影响：监管影响
Susana Murteira,Aurélie Millier,Zied Ghezaiel et al.
Susana Murteira et al.
Background: Repurposing has become a mainstream strategy in drug development, but it faces multiple challenges, amongst them the increasing and ever changing regulatory framework. This is the second study of a series of t...
Economic impact of new active substance status on EU payers' budgets: example of dimethyl fumarate (Tecfidera(®)) for multiple sclerosis [0.03%]
欧盟各国支付者的预算中纳入新的活性物质产生的经济影响：以二甲基富马酸（Tecfidera(®)）治疗多发性硬化症为例
Mondher Toumi,Guy Jadot
Mondher Toumi
Background: Recently, collaboration between regulators and payers was set up and was mainly focused on evidence generation along product clinical development. However, neither the regulatory path nor the new active substa...
Duccio Urbinati,Cécile Rémuzat,Åsa Kornfeld et al.
Duccio Urbinati et al.
Background and objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical h...
The value of quantitative patient preferences in regulatory benefit-risk assessment [0.03%]
定量患者偏好数值在监管效益风险评估中的价值
Mart Oude Egbrink,Maarten IJzerman
Mart Oude Egbrink
Quantitative patient preferences are a method to involve patients in regulatory benefit-risk assessment. Assuming preferences can be elicited, there might be multiple advantages to their use. Legal, methodological and procedural issues do h...
And if the discovery of new drugs for the treatment of brain diseases depends on Asian countries? [0.03%]
寻找脑部疾病新药取决于亚洲国家？
Jean-Louis Kraus
Jean-Louis Kraus
At the present time, developed countries are making a huge financial effort to support neuroscience research programs, particularly in the fields of advanced research and treatment of brain diseases and mental disorders. A part of this fina...
Pharmaceutical market access in emerging markets: concepts, components, and future [0.03%]
新兴市场药品市场准入：概念、构成及未来展望
Anuj Kumar,Karthaveerya Juluru,Phani Kishore Thimmaraju et al.
Anuj Kumar et al.
This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalatin...
Drug repurposing in pharmaceutical industry and its impact on market access: market access implications [0.03%]
药物再定位在制药行业中的作用及其对市场准入的影响：市场准入影响分析
Susana Murteira,Aurélie Millier,Mondher Toumi
Susana Murteira
Background: Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and ...
Health technology assessment in middle-income countries: recommendations for a balanced assessment system [0.03%]
中等收入国家的卫生技术评估：建立均衡评估体系的建议
Dávid Dankó
Dávid Dankó
Because of significant differences in institutional contexts, health technology assessment (HTA) systems that are in place in core pharmaceutical markets may not be suitable, fully or in part, for middle-income countries (MICs) and for othe...
Challenges in generating costs and utilisation rates associated with castration-resistant prostate cancer [0.03%]
与去势抵抗性前列腺癌相关的成本和利用率的数据收集难点及应对策略
Siobhan Bourke,Richéal Maria Burns,Caroline Gaynor
Siobhan Bourke
Background: Prostate cancer (PCa), the most commonly diagnosed cancer among men in the United States and Europe, is an escalating resource allocation issue across healthcare systems in the Western world. The impact of ske...
Pharmaceutical expenditure forecast model to support health policy decision making [0.03%]
药品开支预测模型支持卫生决策政策
Cécile Rémuzat,Duccio Urbinati,Åsa Kornfeld et al.
Cécile Rémuzat et al.
Background and objective: With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of v...