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For people who are authors of books and have perhaps self pub

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

lished previously it might be a good idea to turn your book i

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

Examples of combination products may in

to an eBook. If your book is a nonfiction book it may be poss

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

ble to break the chapters down and perhaps elaborate on some

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

of the subjects and 2-3 E-books from that one work. It does n

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

Combination pro

t make sense to take a book which you may have produced that

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

erhaps sold less than 10,000 copies since you self published

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

it and then not turn it into something that can be seen by ma

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

y more people.

If you break down the subjects properly into

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

he books you may be able to get quite a few more people readi

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

g your book and you can charge a very low price. The lower t

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

Following aspects would a

he price the more people who will afford it can buy it and eB

dd to the challenges in developing combination products:

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

oks cost very little to produce.

There are many successful o

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

line eBook writers and authors and you can go to Lulu.com and

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

see all the eBooks there available to all online Internet bu

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

ers. What do you have to lose? And why would you allow such

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

Professional from academic institutions, pharmaceutical industries, health care indust

information that you spent so much time and hard work and eff

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

ort in producing go to waste. Isn't it time that you made a

.

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

econd edition anyway and this might be a way. Think of this

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

Companies that provide selfless information through particip

n 2006 and maybe you might find success in the eBook business

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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