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For over 44 years, wow that seems like a very long time, I worked as a registered nurse. I worked in every area of nursing, (hospitals, teaching, psychiatric, de

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

tox units, prisons, etc) and not only did I work a J.O.B. (Just Over Broke) but I also had to work two jobs for years to support my family as a single mom. That

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

Examples of combination products may in

is enough to make one not only tired but still just enough income to pay the bills.

Does any of that sound familiar to you? I would venture to say that it sound

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

s way to familiar to way too many.

Let's take a look at why that seems to be the norm. Well, just to date myself, in the "good ole 60's" if you can imagine, our

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

salaries were less then three hundred a month. Can you imagine that either? But, guess what, the gas was only 10 cents a gallon and bread was barely a dime. Cars

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

Combination pro

cost less then a thousand dollars and houses were around fourteen thousand for a nice home.

So take the cost of living and the rise in all products and on and

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

on, it is very easy to see where we have come to the just getting by. But, now what is the difference in the ones that have learned the "secret" and the ones tha

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

t are in the top five percent of the money earners or fortunes for businesses?

Do you know the difference? And, do you know why so many people do not? And, why

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

o many, oh so many are just eeeking a living and just existing from pay to pay from day to day? Now, I am not an economist but I have myself personally lived fro

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

m those pays to pays. No, I do not just exist especially on a day to day spiritual and economical level now. But, I do know how it feels to worry about bills and

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

how to keep the kids fed and to have the stove, refrigerator, and the car all break in the same day.

But, I also know the real feeling of a sense of accomplish

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

Following aspects would a

ment of not only coming through the tough times but also staying on focus and target to get to the other side of the tunnel. And, oh by the way, also learning th

dd to the challenges in developing combination products:

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

"secret" as well.

Do you get ahead in a J.O.B.? But, if you have to work and pay the bills, then how to you get out of the rut and get to the other end. Especi

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

ally when you work and get home and the demands of the family and you being too tired to even think about being creative or making an attempt at working for your

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

self.

Before you think that all is so bleak and there is no way out for you, let me explain how I was able to work two jobs, raise two great kids (now 38 and 39

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

), and also get out of the J.O.B. and finally work at home on a full time basis for myself. How? I first learned the "secret" and then I set my goals, made my pl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns, and acted on the plans.

Seems too simple, right? Well, it works and that is why I like helping so many people get started because I know there is a better w

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

ay. I know how the freedom of time feels even though I still spend time working, it is for myself and my team that I work with. Not for the B.O.S.S. or with peop

.

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

le that are negative and I would rather be around.

I am going to leave you with this last question for now. Would you rather stay doing the same thing that you

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

Companies that provide selfless information through particip

are doing in the next five years? Or, would you rather learn a new and better way so that you can live the lifestyle of your dreams.. whatever your dreams may be

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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