It may be a while before I resume posting regularly to the blog again. I left my home in Galveston, TX a couple of days ago, fleeing from Hurricane Ike and am not sure when will I be able to return.
Thanks for reading!
Saturday, September 13, 2008
Wednesday, September 10, 2008
The Drug Regulatory Process in the United States
Medical writers working in the regulatory environment must know well the process a candidate drug goes through before approval by the FDA. Below is a quick overview of the drug development process.
1. Preclinical Testing
Laboratory tests and animal studies are conducted. These studies show biological activity of the compound in relation to animal models of the targeted human disease or condition. Along with these results, the compound is evaluated for toxicology.
2. Investigational New Drug Application (IND)
An Investigational New Drug Application (IND) is filed with the U.S. Food and Drug Administration (FDA) after completion of preclinical testing. This allows testing of the drug in humans to begin.
3. Phase I Clinical Trials
Small numbers of healthy volunteers are tested with the drug to determine its duration in the bloodstream and the drug’s initial safety profile. This study also provides information about how the drug is absorbed, distributed, metabolized, and excreted in humans.
4. Phase II Clinical Trials
Approximately 100-500 volunteer patients with the disease or condition are tested with the drug to assess its effectiveness.
5. Phase III Clinical Trials
A large number of patients (usually at least 1,000-5,000 subjects) in clinics and hospitals are tested and monitored closely by physicians to confirm efficacy and to identify any adverse effects.
6. New Drug Application (NDA)
If the drug is determined to be safe and effective, an New Drug Application (NDA)
is filed with the FDA at completion of the clinical trials.
7. Drug Approval
Once the FDA approves the NDA, physicians may prescribe the drug to patients.
8. Phase IV
If patients report adverse effects after taking the drug, the FDA may require Phase IV trials to evaluate long-term effects of the product.
The Regulatory Writing Online Course describes this process in depth.
1. Preclinical Testing
Laboratory tests and animal studies are conducted. These studies show biological activity of the compound in relation to animal models of the targeted human disease or condition. Along with these results, the compound is evaluated for toxicology.
2. Investigational New Drug Application (IND)
An Investigational New Drug Application (IND) is filed with the U.S. Food and Drug Administration (FDA) after completion of preclinical testing. This allows testing of the drug in humans to begin.
3. Phase I Clinical Trials
Small numbers of healthy volunteers are tested with the drug to determine its duration in the bloodstream and the drug’s initial safety profile. This study also provides information about how the drug is absorbed, distributed, metabolized, and excreted in humans.
4. Phase II Clinical Trials
Approximately 100-500 volunteer patients with the disease or condition are tested with the drug to assess its effectiveness.
5. Phase III Clinical Trials
A large number of patients (usually at least 1,000-5,000 subjects) in clinics and hospitals are tested and monitored closely by physicians to confirm efficacy and to identify any adverse effects.
6. New Drug Application (NDA)
If the drug is determined to be safe and effective, an New Drug Application (NDA)
is filed with the FDA at completion of the clinical trials.
7. Drug Approval
Once the FDA approves the NDA, physicians may prescribe the drug to patients.
8. Phase IV
If patients report adverse effects after taking the drug, the FDA may require Phase IV trials to evaluate long-term effects of the product.
The Regulatory Writing Online Course describes this process in depth.
Monday, September 8, 2008
Attracting New Writing Clients
By Cheryline Lawson (Guest blogger)
Every business needs new clients and writers are no different. If you want to start out as a freelance writer and are confident with your skills, the next step is to showcase your craft by finding writing assignments that match your skills.
There are millions of Internet business owners that need fresh content press releases, articles, blog posts, and forum posts. There are more businesses online than there are writers. It is really very easy to find clients online.
However, in the beginning, you may have to accept smaller jobs and when you build your portfolio, other clients will notice you. You can start your own blog and post content on your blog frequently. You can use those blog posts as samples, so make sure the posts are between 400 to 500 words long.
Your blog will act as a working resume so that the online business world can take notice of you and your skills. You can use your blog for additional income by placing affiliate links that include books and products about writing or working from home.
Be sure to have a sample writing resume. Place the resume on your blog, but exclude your address and phone number. Be sure to include your email address as contact for your prospects or clients. You should write your best articles and post it to your blog. Write on different topics to show your versatility.
You can also search for freelance writing opportunities online. You can hang out at different forums and make wise and informative comments so that Internet Marketers can get a sneak preview of your expertise. Make sure you include your blog website in your forum signature file.
You can attract new clients by bidding on writing projects at elance.com and getafreelancer.com. However, you do need a good writing portfolio and writing samples for your client to view. In most instances, the client will request a sample or two.
Be careful of clients who want to underpay you for your skills. It happens. You will be offered as low as $2 per 500-word article. Even if you are starting out, this is really low. If you are confident and know that you are good writer, do not settle for low pay per article. It is a waste of your time. I know this might seem very harsh to a new client, but if a client wants good quality content, he or she will pay more than $2 because in the end, the client will get what they pay for.
Be professional at all times and treat your writing assignments as if it were your very own. Do a good job and the client will want to do repeat business with you. If you get a client who only needs a few articles, always follow up with the client so that you are not forgotten.
You will attract specific clients if you write in a certain niche market. Let's say that that you are a skilled medical writer, you would then find those clients that have medical writing projects or technical writing projects. You can pick your niche and stay in your niche or you can be a writer who is an excellent researcher who can write on any topic. You have more options when you write on any topic.
Cheryline Lawson is a passionate writer who uses her talent to alert the public about issues that need addressing. She is a hired writer who writes books, ebooks, ecourses, articles, blogs, forum posts and reviews. Find out more by visiting her website. Article source here.
Every business needs new clients and writers are no different. If you want to start out as a freelance writer and are confident with your skills, the next step is to showcase your craft by finding writing assignments that match your skills.
There are millions of Internet business owners that need fresh content press releases, articles, blog posts, and forum posts. There are more businesses online than there are writers. It is really very easy to find clients online.
However, in the beginning, you may have to accept smaller jobs and when you build your portfolio, other clients will notice you. You can start your own blog and post content on your blog frequently. You can use those blog posts as samples, so make sure the posts are between 400 to 500 words long.
Your blog will act as a working resume so that the online business world can take notice of you and your skills. You can use your blog for additional income by placing affiliate links that include books and products about writing or working from home.
Be sure to have a sample writing resume. Place the resume on your blog, but exclude your address and phone number. Be sure to include your email address as contact for your prospects or clients. You should write your best articles and post it to your blog. Write on different topics to show your versatility.
You can also search for freelance writing opportunities online. You can hang out at different forums and make wise and informative comments so that Internet Marketers can get a sneak preview of your expertise. Make sure you include your blog website in your forum signature file.
You can attract new clients by bidding on writing projects at elance.com and getafreelancer.com. However, you do need a good writing portfolio and writing samples for your client to view. In most instances, the client will request a sample or two.
Be careful of clients who want to underpay you for your skills. It happens. You will be offered as low as $2 per 500-word article. Even if you are starting out, this is really low. If you are confident and know that you are good writer, do not settle for low pay per article. It is a waste of your time. I know this might seem very harsh to a new client, but if a client wants good quality content, he or she will pay more than $2 because in the end, the client will get what they pay for.
Be professional at all times and treat your writing assignments as if it were your very own. Do a good job and the client will want to do repeat business with you. If you get a client who only needs a few articles, always follow up with the client so that you are not forgotten.
You will attract specific clients if you write in a certain niche market. Let's say that that you are a skilled medical writer, you would then find those clients that have medical writing projects or technical writing projects. You can pick your niche and stay in your niche or you can be a writer who is an excellent researcher who can write on any topic. You have more options when you write on any topic.
Cheryline Lawson is a passionate writer who uses her talent to alert the public about issues that need addressing. She is a hired writer who writes books, ebooks, ecourses, articles, blogs, forum posts and reviews. Find out more by visiting her website. Article source here.
Thursday, September 4, 2008
Wednesday, September 3, 2008
Regulatory Writing Course Released
I'm excited to announce the release of the new online course at MedicalWritingTraining.com, "Introduction to Regulatory Writing in the United States."
Many people had asked for this type of course for a long time and it is finally here.
If you are a regular reader of this blog, you have heard (read) me say that regulatory writers are the best-paid professionals in the Medical Writing Industry. In fact, many of them earn six-figures. So, it is natural that you want to break into regulatory writing. This new course can help you do just that.
The good news is that I have created a special introductory offer for the first 30 people who sign up for the course. Click here to read more about this offer and the course.
Many people had asked for this type of course for a long time and it is finally here.
If you are a regular reader of this blog, you have heard (read) me say that regulatory writers are the best-paid professionals in the Medical Writing Industry. In fact, many of them earn six-figures. So, it is natural that you want to break into regulatory writing. This new course can help you do just that.
The good news is that I have created a special introductory offer for the first 30 people who sign up for the course. Click here to read more about this offer and the course.
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