2013年7月14日 星期日
2013年6月18日 星期二
「新療效複方新藥」用詞定義
藥事法第七條所稱的新藥，係指經中央衛生主管機關審查認定屬新成分、新療效複方或新使用途徑製劑之藥品。
12月7日發布的行政院衛生署令(發文字號：署授食字第1011102486號)「修正「藥事法施行細則」部分條文」第二條中，「新療效複方新藥」用詞定義為「已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能，或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。」
相較舊詞定義「指已核准藥品具有新醫療效能，或兩種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者」，更加清楚地描述「新醫療效能」的範疇，舉凡「新適應症」、「降低副作用」、「改善療效強度」、「改善療效時間」或「改變使用劑量」皆是，方便於實務遂行。
參考資料:
※轉載自PST – 國際交流暨資訊學習網
2013年5月9日 星期四
Local CRO in Taiwan
前陣子有位韓國的朋友因工作需求，經由此BLOG寄信問我台灣有哪些本土的CRO公司，為此特地整理了一份清單給他，既然整理完了，乾脆就放上來給有需要的人做參考。裡面有很多大家都沒聽過的公司在內，但不用懷疑，他們還是真正的CRO公司，只是很少聽到而已，因為這些公司可能得真正在臨床試驗領域的人才會去接觸到。
1. Global CRO.
2. Taiwan Local CRO
2. BA/BE Study CRO
1. Global CRO.
- 百瑞精鼎 (PAREXEL)
- 華鼎
- 維州 (http://www.vcro.com.tw/)
- 晉加
- 佳生
- 明生
- 全面顧問 (SMO) (http://www.518.com.tw/job-comp_detail-1075340.html) (http://www.ttmc.com.tw/)
2. BA/BE Study CRO
- 明生
- 佳生
- 維州
- 世宬 (BE & phase I)
- 怡發
- 昌達 (http://www.qps.com/)
3. 兩岸醫材 CRO
Clinical Trial Assistant 兼任 CRC的生活。
雖然自己有了130多小時的GCP，也在藥廠做過CRA去送審計畫、專案管理、以及拜訪醫師打通關等等，但一直都沒有機會體會實際收案的狀況。
在今年尋覓CRA工作還未有消息前，剛好國防有個CTA兼任CRC的職務，就很快的答應去面試也獲得錄用，雖然目前才經過一個月，很忙碌但卻很快樂，說也奇怪，若想要有條理的說明對臨床試驗的工作為什麼感興趣，實在是很難說清楚講明白，但為了一堆paper work或是做24小時PK實驗，得7點到辦公室，8.9點才離開辦公室卻也不會覺得心不甘情不願（被老婆看到會被罵死....都不用理老婆了），有興趣這件事，真的很奇妙。
不過目前比較累人的是，一個人要負責8間醫院的收案，希望等自己時間滿檔之後，老闆願意讓我請全職的CRC，也希望將來的CRC能有好表現。
在今年尋覓CRA工作還未有消息前，剛好國防有個CTA兼任CRC的職務，就很快的答應去面試也獲得錄用，雖然目前才經過一個月，很忙碌但卻很快樂，說也奇怪，若想要有條理的說明對臨床試驗的工作為什麼感興趣，實在是很難說清楚講明白，但為了一堆paper work或是做24小時PK實驗，得7點到辦公室，8.9點才離開辦公室卻也不會覺得心不甘情不願（被老婆看到會被罵死....都不用理老婆了），有興趣這件事，真的很奇妙。
不過目前比較累人的是，一個人要負責8間醫院的收案，希望等自己時間滿檔之後，老闆願意讓我請全職的CRC，也希望將來的CRC能有好表現。
2013年1月23日 星期三
Suits S01E03 MEMO
The dinner party is a classic, if overused, plot point in TV programming. Dating back to at least the 1950s in programs like the "Leave it to Beaver" episode "Teacher Comes to Dinner," the dinner party has also been a focal point in episodes of "Seinfeld," "The Vampire Diaries," "Family Guy," and "Married with Children." Most often, the dinner party is high stakes for the main characters because a boss, teacher, or other authority figure will be present. The trope has become so entrenched in pop culture that there is even a reality game show called "The Boss is Coming to Dinner" that forces job applicants to impress a potential boss in order to move up the corporate ladder.
2013年1月4日 星期五
Plan On It: 4 Goals You Should Have For 2013, And How To Get There
Plan On It: 4 Goals You Should Have For 2013, And How To Get There
Strength athletes are creatures of habit. They do the same thing day in and day out: go to the gym, lift things, put them down, go to work, go home. Ingest this much of that macro before you do the other thing. Along the way, they get big, they get strong, and sometimes they get bored.
So how do you cure boredom? Set a challenge! Just for something different, forget about adding more weight to the bar. In fact, forget the bar altogether. Set a challenge that involves only your body weight. It will work your upper body, lower body, and core, and increases your muscular endurance along the way.
Endurance? Don't scoff. Life is not always about a quickie, and we're not talking about running a marathon here. If you accomplish these four strength-endurance goals by the end of the year, you can expect a leaner body, added muscle mass, and improved low-back health for your efforts.
The challenge has been set!
Rising Star: Fitness Model Jeff Seid Talks With Simplyshredded.com Quick Stats:
Rising Star: Fitness Model Jeff Seid Talks With Simplyshredded.com
Quick Stats:
Age: 18
Height: 6’0 – 183 cm
Weight: 185 lbs. 84 kgs
WBFF Bikini Pro Laura Michelle Prestin Talks Simplyshredded.com
WBFF Bikini Pro Laura Michelle Prestin Talks Simplyshredded.com [Updated 2012]
[轉貼] Lean Machine: Cover Model Ben Booker Talks With Simplyshredded.com
Lean Machine: Cover Model Ben Booker Talks With Simplyshredded.com
How did you get started with bodybuilding?
In high school I had to lift for sports but never got serious about lifting until I got in a wreck and broke my back three weeks into football season of my senior year. After about 2 months of bed rest, and 3 months of rehabilitation I began to lift weights to regain some strength. Missing all sports in my senior year, the first thing that I was able to do was bench press. I was 135 pounds when I got out of bed rest and 165 when I graduated. It was during college when I met a guy in the weight room that looked how I wanted to look, so I asked him for his workout. He gave me a bodybuilding book that I read and got his workout out of, it was called “Big Beyond Belief”. I have been on this same program now, on and off, ever since my freshman year in college.
It wasn’t until about 3 years ago, though, that I started combining the nutrition and supplementation that has sent my bodybuilding success through the roof!
[轉貼] Beast Mode: Fitness Model Simeon Panda Talks With Simplyshredded.com
Beast Mode: Fitness Model Simeon Panda Talks With Simplyshredded.com
Quick stats
Age: 26
Height: 6’1” – 185 cm
Weight: 230 lbs. – 104 kgs
Gym Class: The Top 10 Most Common Training Mistakes And We Show You How To Fix Them
Gym Class: The Top 10 Most Common Training Mistakes And We Show You How To Fix Them
Get out your workout logbook and tighten up your wrist straps as we count down the 10 most likely derailments of your training progress and explain how to avoid them. Class is in session.
Featured Model: Luke Guldan
[轉貼] The Ultimate Bulking Guide For Maximum Muscle Gains – Written By Chris Martinez
The Ultimate Bulking Guide For Maximum Muscle Gains – Written By Chris Martinez
During off-season dieting, we’re almost 100% certain that you have been down multiple avenues looking for the most efficient way to build muscle mass while trying to avoid excess fat gain.
A lot of us have made mistakes, some of us have gotten results out of spite, not because what we did was optimal, some of us have just flat out tried everything and are still scratching our heads in confusion.
2013年1月3日 星期四
[轉貼]50 Rules Of Fat-Burning: Simplyshredded.com Collects The Strongest Clinical Research From Around The World
50 Rules Of Fat-Burning: Simplyshredded.com Collects The Strongest Clinical Research From Around The World
Whatever your doing must not be working. Why else would you be reading this?
You swapped fried chicken for grilled and your treadmill is finally getting more attention than your TiVo. But your body isn’t quite where you want it to be. Don’t worry: Your bag of fat-burning tricks isn’t empty yet. We’ve collected 50 comprehensive tips, all backed by more science than a NASA shuttle launch. By the time you’ve incorporated these fat-burning gems, we’ll have 50 more for you. But by then, you probably won’t need them.
訂閱：
文章 (Atom)