相关实验视频
Updated: Jan 15, 2026

08:36
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
1.5K
Abemaciclib早期访问 - 一个意大利的经验.
Concetta Calabrò1, Eleonora Cannella2, Patrizia Nardulli1
1Struttura Complessa di Farmacia IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Frontiers in oncology
|October 15, 2025
概括
在意大利,高风险乳腺癌患者在名义价格下早期获得Verzenios (Abemaciclib) 证明了显著的疗效和长期益处,同时也产生了大量的医疗保健节省.
科学领域:
- 在瘤学瘤学.
- 药物经济学 药物经济学
- 临床药理学 临床药理学
背景情况:
- 意大利法律允许在C ((nn) 分类下进行谈判前的药物营销.
- 自2022年4月以来,Verzenios (Abemaciclib) 已在这种C(nn) 状态下提供高风险乳腺癌辅助治疗.
- 这促进了患者早期获得新疗法的机会.
研究的目的:
- 评估意大利早期Verzenios (Abemaciclib) 访问对现实世界的影响.
- 评估Verzenios加内分泌治疗 (ET) 在高风险乳腺癌中的临床疗效和耐受性.
- 分析意大利国家卫生系统的经济影响.
主要方法:
- 分析了MonarchE研究结果的疗效和安全结果.
- 考虑了关于患者数量和治疗持续时间的现实数据.
- 经济建模用于计算与避免转移性疾病相关的成本节约.
主要成果:
- 在高风险患者中,Verzenios加ET可将复发和远程转移风险降低35%.
- 长期福利 (IDFS,DRFS) 持续长达48个月.
- 使用名义定价的C ((nn) 方法为意大利国家卫生系统带来了显著的成本节省,避免了与转移性复发相关的成本.
结论:
- 通过C(nn) 类别早期获得Verzenios为高风险乳腺癌患者提供了实质性的临床益处.
- 这一策略在经济上是有利的,通过预防昂贵的转移性疾病,可以节省大量资金.
- 意大利的Cnn) 模型表明,在财政责任下,早期获得创新的癌症治疗方法的可行途径.
相关概念视频
Clinical Trials
10.1K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.1K
Clinical Trials: Overview
4.6K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K
Preclinical Development: Overview
5.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.8K
Bioequivalence studies: Biowaivers
225
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
225
Drug Administration and Therapy Phases: Overview
1.3K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.3K
Bioavailability Study Design: Healthy Subjects Versus Patients
143
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
143

