巴黎人注册网站的持续增长取决于巴黎人注册网站的研究和发展的成就

为新疗法的发现和发展创造最佳条件, 巴黎人注册网站遵循最佳的开发流程，以确保目标候选人从构思到在市场上注册的进展.

Discovery

LEO Pharma拥有一个完全集成的药物发现平台，在包括药物化学在内的各个科学学科之间具有很强的相互作用, bioinformatics, molecular and cell biology, pharmacology and pharmacokinetics. 

From idea to drug candidate

识别新产品的机会需要对巴黎人注册网站试图治疗的疾病的分子病理学有深入的了解. 世界领先的前沿科学知识与好奇心和对帮助患者的浓厚兴趣相结合，是成功的先决条件. We follow the frontline in pioneering science, treatments, competitor pipelines and moves, as well as the scientific community around our key focus indication. 

在一个迭代的过程中，包括新靶点的识别和实验生物学分析, we work to understand how our compounds work on the molecular level; how they interact with the biological target and how this intervention will translate into the disease in patients. This profiling includes a variety of biochemical and cell-based assays. 
 

体内药理学家在靶相关和机制的体内模型中测试分子. 分子分化和分析是为了获得所需的药效学效果和药代动力学特征.
 

When the most interesting drug molecules have been selected, 巴黎人注册网站的重点是对化合物的生物效应有透彻的了解. 这包括在更先进的模型中进行分析，以确定最有希望的化合物，而不会产生任何可预测的副作用, 深入了解其作用机制，建立最佳治疗方案.

Preclinical development

In the preclinical development phase, we assess the risk of the drug candidate to human health prior to, during and after clinical development. We plan, 执行和编制非临床监管安全性研究，并提交开发候选药物或产品，以支持巴黎人注册网站药物的临床评估和营销.

All preclinical safety studies (e.g. 毒理学和药物代谢)外包给专门的合同研究机构(cro)。, and we have an established procurement function handling all contractual steps.

进行“操作自由”分析，以确定与候选药物相关的不存在阻断专利权. We subsequently prepare patent applications covering the new compounds, therapeutic uses thereof, formulations and processes.

Pharmaceutical formulation

Potential new molecules continue to the pharmaceutical formulation phase, in which the choice of ingredients to complement the pharmaceutical substance, the dosage form (e.g. injectable, cream, ointment, tablet, gel, foam, etc.) and the manufacturing methods are designed and tested. 最佳的药物配方确保药物分子的正确吸收进入人体与最小的副作用.

Development

The drug candidate has now advanced to the clinical testing in humans, which traditionally takes five to seven years.

In phase I, 巴黎人注册网站在健康的志愿者身上测试药物，从很小的剂量开始，然后增加剂量，直到预期剂量对患者有效. 评估药物的安全性和耐受性，并进行药代动力学评估.
 

在第二阶段，药物在少数患者中进行测试，并评估对目标疾病的影响. In addition, the dosing of the drug and the safety in patients are investigated.
 

在III期，II期的研究结果在大量患者群体中得到证实. The purpose is to demonstrate efficacy and safety in statistically robust, unbiased studies, 通常包括来自几个国家许多医院的数百名患者, and the trials are traditionally controlled and double-blind. 巴黎人注册网站与全球1000多名调查人员合作进行试验.
 

After successful phase III studies, the drug may obtain marketing authorisation, 并且通常在几个第四阶段试验中进一步研究，以确定药物在治疗疾病中的确切作用.

Registration

Throughout the drug development process, from early discovery through launch of a product, 监管事务提供投入和战略，以确保制定的数据和文件适合世界各地卫生当局的最终注册. 巴黎人注册网站的法规事务部分析和汇编来自临床和非临床研究的文件, quality data and the manufacturing process.

该文件以电子方式提交给监管机构进行评估，之后-如果发现数据足以证明药物的质量, efficacy and safety - we are granted marketing authorisations.

The major part of regulatory activities is after launch of the new product; Changes in the manufacturing process require approval from the regulatory authorities, new indications, 新的药物配方或额外的安全信息需要改变标签, and new markets and requirements from regulatory authorities require updates.

Patient safety

Throughout the life-cycle of LEO Pharma products, 巴黎人注册网站不断提供有关巴黎人注册网站产品的利益和风险的最新信息, based on information from many sources such as preclinical and clinical trials, case reports from healthcare providers, consumers, literature and quality complaints.

International and national legislation regulate the field strictly. 利奥制药遵循要求，巴黎人注册网站在所有市场对巴黎人注册网站的产品进行持续和集中的安全监督. 监管机构不断了解巴黎人注册网站的评估和活动，以维持他们对利奥制药产品的信心.
 

In all phases, 巴黎人注册网站调查并记录了药物的毒性以及药物的管理如何与生理过程相互作用, including building knowledge on how the drug is absorbed, distributed, metabolised and excreted. 这是记录新药临床疗效和安全性的重要知识.