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How It Began

Yes, it is true, I am addicted to ebooks! It does not matter what kind, what the subject matter is, how old, I am addicted! How did

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

I come about this obsession? There is a simple answer.

A few months ago, I decided I wanted to write ebooks like so many of my mentors were doing

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

. I did not know the first thing about writing, so I had to research. One book led to another and another. I read about writing articles, creating

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

a website, how to draw traffic, how to attract Google to your website, (as well as other search engines,) health issues, anything that was in pri

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

t!

Was the information helpful in teaching me how to write? Well, you be the judge. I don’t profess to be great at it, but I do think I can make

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

some points.

Not that I do not enjoy the ebooks, but because of the need for them, my computer is suffering! The desktop is full of ebooks I will

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

probably never read, although there are some gems in there that I will read again and again. I have already had to increase memory due to my addi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ction.

Meanwhile, this is what you need to know If you find you are addicted.

•Carefully select the ebooks you will REALLY read don’t settle for

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

junk.
•Do not download them all to your desktop. Put some on a cd and file for future use.
•Compare the ebooks, as you will probably fi

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nd, many are the same exact ebook, but with different zip names, so you are wasting resources on your computer that you will need later for other

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

projects.
•Every now and then, go through your ebooks, as many expire, and will not open any longer, or links expire, so that you are unable

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

to utilize the resources they speak of. Seriously, if you plan to use an ebook as a bonus to your members, do you think they would consider it val

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

able if the links do not work?
•Ask yourself, 'What is the purpose of me having this ebook? Will it help me in some way? Will I enjoy readin

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

g it?' If you answered no to any one of the questions, you may want to examine if you really need to keep it.
•ALWAYS, ALWAYS, ALWAYS be car

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

eful when downloading ebooks. I cannot stress it enough, as so many out there today do contain viruses. Be sure that you carefully scan your ebook

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

s when you download them so you do not end up with a fried harddrive.
•Keep in mind; the BEST ebooks are probably going to cost you. If you

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ait until they become free, the information inside will probably be useless to you, as the demand for the product or information is no longer an i

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ssue.

Now that you have learned how to fight the ebook addiction, take the time to do an inventory of your own personal collection, and

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

possibly do a bit of spring cleaning. Save your computer resources for important things like the articles YOU will write someday.

There are many

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

more points to be made on this subject; I have just hit the tip of the iceberg!

If I have taught you one point, or made you smile, my job is done

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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