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Up to this point, you’ve worked on yourself…the stinkin’ thinkin’ thing…you’ve found out that you’ve already “written” several dozen e-books in your life…you’ve also found out that it ain’t so b

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

ad to fail! You’ve also learned how to work on your mind…or, rather, work with it a LOT better. That’s a good little bit in just 15 pages or so!

The next 5 chapters are VERY task-oriented. The

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

Examples of combination products may in

y’ll give you step-by-step instructions on how to actually turn an idea into a good, profitable e-book. You’ll be working pretty hard during those 5 chapters.

But, if I had to pick the most im

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

ortant chapter in this book…it’s this one!

In this chapter we’re going back to working on you…and that’s the most important part of this whole project.

Look, it’s time to REALLY figure out if

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

this is what you want to do…really do! If you’re not willing, or ready, to set aside 4 hours for each of the next 5 days/nights to finish up your very own product…your very own e-book…then you

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

Combination pro

need to take a minute and think about that.

Why are you even reading this book? Something must’ve struck a chord in your brain…something must’ve sparked a NEED in you…or you wouldn’t have boug

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

t this book in the first place, right? Let’s look a little deeper here.

What is it that you want? What do you want enough to give up time away from your family…time away from your TV or your

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

video games or your newspapers or books…time away from sleep? Can you name it? Can you put a name to what you REALLY want, NEED to have?

You have to have a concrete goal or you’re never going

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

to get what you want and need. Setting a goal helps you turn that want of yours…I really want a brand new 2006 Ford Mustang…into a need…I NEED a brand new 2006 Ford Mustang. There’s a world o

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

difference between a want and a need. A person with a full stomach may say, “I want a piece of pie.”, but a person who hasn’t eaten in a few days says, “I NEED something to eat.” You have to

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

turn your wants into needs.

Here’s how you do that in the case of this book.

Write down…on your yellow legal pad…with a pen…the following statements.

I NEED TO HAVE MY OWN E-BOOK!

I WILL HAV

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

Following aspects would a

E MY OWN E-BOOK BY (5 days from now)!

I’LL GET MY OWN E-BOOK BY DOING THE FOLLOWING STEPS: 1. BY FOLLOWING CHAPTER 1 OF DENNIS’ BOOK, 2. BY FOLLOWING CHAPTER 2 OF DENNIS’ BOOK, 3. BY FOLLOWI

dd to the challenges in developing combination products:

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

G CHAPTER 3 OF DENNIS’ BOOK, 4. BY FOLLOWING CHAPTER 4 OF DENNIS’ BOOK, 5. BY FOLLOWING CHAPTER 5 OF DENNIS’ BOOK.

WHEN I GET MY E-BOOK WRITTEN, I’LL REWARD MYSELF BY … (Here you’ll pick a r

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

eward…maybe not a new car, but a good book or a great time with the kids at an arcade, a great romantic meal with the spouse)

Then you HAVE to sign this sheet of paper, date it and hang it up r

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

ight there beside your computer and anywhere else in your home that you see a LOT every day. Maybe your bathroom or on the ceiling above your bed!

But, before you hang it up, go on Google and

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

ind a picture that represents what you want. If it’s the latest version of X-Site Pro, then get a picture of it and tape it to the sheet you just filled out. If it’s a romantic dinner, find a

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

Professional from academic institutions, pharmaceutical industries, health care indust

picture of 2 gorgeous people having a fancy dinner with all of the trimmings.

Leave that piece of paper up until you get what you need.

What I’m after here is getting you to make a commitment

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

to yourself…and your family…that you’re going to do this. Without a commitment, you’re really increasing the odds that you’ll never get that e-book done…you’ll never have a product of your own…

.

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

ou’ll never really be in control of your own business destiny.

This is such a tiny commitment to make…4 hours a night…for 5 days…that’s not really so much now, is it? Don’t you owe it to yours

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

Companies that provide selfless information through particip

elf and your family to REALLY do this?

It’s YOUR decision! If you’ve truly made the decision to go on, then let’s get going!

Copyright (c) 2006 By Dennis Lively and LiveMark Associates, L.L.C

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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