Myo-inositol in a new pharmaceutical form: a step forward to a broader clinical use

Objective: Dose-dependent side effects related to myo-inositol (MI) oral administration represent a significant shortcoming for its clinical use. Aiming to search for a pharmaceutical form able to be better absorbed, the pharmacokinetic (PK) profile of the new manufactured MI soft gelatin capsule form was evaluated and compared with the commercially available MI powder.

Research design and methods: A single-dose relative trial, consisting of four phases, was performed on 20 healthy volunteers who received different doses of MI powder and MI soft gelatin capsules. PK profiles related to the two pharmaceutical forms were obtained by analysis of MI plasma concentration, and the respective MI bioavailability was compared.

Results: The administration of MI powder and MI soft gelatin capsules resulted in a different bioavailability. MI soft gelatin capsule form showed similar PK parameters compared with three times higher doses of MI in powder form.

Conclusions: MI soft gelatin capsules displayed an improved bioavailability, allowing to substantially reduce the administered dose and to minimize the dose-dependent side effects. Considering the number of conditions in which MI supplementation is recommended, this evidence could support a broader use of MI in clinical practice.     

2004年在美国即将上市的十大新药

2004年，至少有10种药物有望能获得美国FDA的上市许可。这些药物的年销售峰值均可达10亿美元以上，某些药物甚至每年可产生几十亿美元的收人，成为未来的“重磅炸弹”。     

Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study

This paper reviews the scientific and ethical issues surrounding the conduct of bridging studies in patients with Alzheimer's disease (AD). Bridging studies, so called because they facilitate the transition from phase I to phase II development, are late phase I safety/tolerance studies which determine the maximum tolerated dose (MTD) in patients before initiating phase II efficacy studies. Determining the MTD in patients is important because we have found that AD patients appear to respond to cholinergic compounds differently from normal volunteers, reaching a different MTD. Preliminary evidence of dose-related efficacy with two cholinergic compounds lends support to our contention that determination of the highest tolerated dose maximizes the potential to detect efficacy.We will review the early clinical development of several cholinergic compounds and make recommendations for the design and conduct of bridging studies based on our experience. A fixed-dose panel design with dosages based on the MTD determined in normal volunteers is recommended. In order to minimize risk to the patients, ensuring that scientific benefits outweigh the risks, a bridging study must be supported by detailed preclinical toxicology, by a clinical research unit that is prepared to handle unexpected contingencies, and by the oversight of a competent, multi-disciplinary review board. Patients should be in good physical health (excluding AD), and a comprehensive informed consent procedure must be instituted. Carefully planned and well run bridging studies represent a scientifically and ethically sound approach to drug development in the Alzheimer's population.     

2007年药物新制剂回顾与展望

2007年,技术创新、给药途径创新、给药方案创新和包装创新推动了药物新制剂新剂型不断上市.值得注意的是,2003年5月20日我国对法国博福益普生制药有限公司的醋酸兰瑞肽注射用粉针(Somatuline Powder for Injection)给予药品行政保护,2007年8月31日美国FDA批准兰瑞肽储库型控释注射剂(商品名:Somatuline Depot)作为新分子实体(New Molecular Entity,NME)上市.     

创新性化学药物杂质研究目的、思路与技术要求

权衡杂质风险和水平一直是创新药物关注的重点,国内外相应指导原则对创新药物的杂质都有相关指导原则予以阐述.众所周知,杂质不可能完全消除,只能在实际生产和技术审评中,将杂质控制在尽可能低的水平,以保证药品的安全性.本文结合杂质研究指导原则,对创新药物杂质研究的思路和技术要求进行了探讨.     

浅谈医药营销中的企业伦理

与一般消费品不同,药品是一种直接关系到最终消费者生命与健康的特殊商品。在生产经营中,医药企业既要为了实现赢利的目的而积极参与残酷的市场竞争,同时又必须对消费者和社会承担起重要的责任。因而,医药企业在形成企业的营销理念以及在药品的营销过程中对“利”与“德”的取舍或偏重直接影响着企业的伦理取向以及企业的整个经营行为。本文仅就国内医药企业的营销理念及其部分营销行为的企业伦理（businessethics）作一初浅的探讨。     

2008年上半年美国FDA批准的新药

2008年上半年,美国FDA共批准了7个新分子实体和2个新生物制剂。本文按获批时间,就这些新药情况作一简要介绍。1新分子实体1.1依曲韦林(etravirine/Intelence)Tibotec制药公司开发,2008年1月18日经优先审批程序获得批准,用于联用其它抗逆转录病毒药物治疗已经在先抗逆转录病毒疗