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EMS in Viracept--the course of events in 2007 and 2008 from the non-clinical safety point of view.
Author: MüllerLutz, SingerThomas
Original Abstract of the Article :
Viracept (nelfinavir) is an HIV protease inhibitor supplied by Roche outside the US, Canada and Japan. Viracept was first introduced by Roche in 1998. Although newer protease inhibitors have become available for the treatment of HIV, it is viewed as a useful medicine for patients who are intolerant ...See full text at original site
Dr.Camel's Paper Summary Blogラクダ博士について
ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。
* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。
引用元:
https://doi.org/10.1016/j.toxlet.2009.02.005
データ提供:米国国立医学図書館(NLM)
The Viracept Saga: A Desert of Uncertainty
The world of pharmaceuticals is often a complex landscape, like a vast desert with hidden oases and treacherous sandstorms. This research chronicles the journey of Viracept (nelfinavir), an HIV protease inhibitor, through a tumultuous period of contamination and recall. The authors meticulously recount the events that unfolded, from the initial reports of a 'bad smell' to the subsequent identification of ethyl methanesulfonate (EMS) as the culprit. They navigate the complexities of the situation, shedding light on the decision-making process and the extensive efforts undertaken to ensure the safety of patients.
Navigating the Sands of Contamination
The Viracept story is a cautionary tale about the importance of rigorous quality control and vigilance in the pharmaceutical industry. It's like traversing a desert – you must be prepared for unexpected storms and be equipped with the necessary tools to navigate the treacherous terrain.
Transparency and Patient Safety: Paramount Principles
This research highlights the crucial role of transparency and communication in ensuring patient safety. Like desert travelers sharing vital information and resources, the authors emphasize the importance of collaboration between regulatory authorities, pharmaceutical companies, and the medical community to address critical safety issues.
Dr.Camel's Conclusion
The Viracept saga is a testament to the challenges and complexities of pharmaceutical production. It serves as a reminder that, just as desert landscapes can be both beautiful and dangerous, the world of medicine requires constant vigilance and a commitment to patient safety.
Date :
- Date Completed 2009-11-10
- Date Revised 2013-11-21
Further Info :
Related Literature
English
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