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We know when it’s not working; it’s like a slap in the face. We thought it was working, but then something happens to remind us that we haven’t fundamentally changed at all, and we find ourselves back at

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

square one after all these years.

We were smug for awhile, even bragging to friends about what we found and how wonderful it was, but now we see that it was only an act; we haven’t changed. Actually, we

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

Examples of combination products may in

ere better off before we became so smug and intolerant about our views that, alas, have proven so shallow. This is difficult for anyone to face, and it’s completely understandable if we continue to play-a

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

t, even after knowing in our heart of hearts that it’s over – that a fundamental shift in the deepest part of our being just never happened.

Sometimes we luck out on the other side of an unexpected traum

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

. We might recover from the deep shock of an accident, or an illness, and find ourselves dramatically transformed where our old worries and concerns have somehow evaporated into coolness and composure. Th

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

Combination pro

baseless and overstated uncertainties that had previously suffocated us now disappear, and all we feel is a baffling sense of affection toward everything, and an urge to help in ways that never occurred

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

o us in the past.

These shifts in consciousness don’t happen by reading words in a self-help book, or by following someone’s well-intentioned advice; these shifts take place when logic and cunning can’t

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

uite keep up with the stark reality of a desperate situation. In that brief interval where powerful events override all thought, opinion, and emotion, something ineffable floods our momentarily empty bein

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

, and we, as well as our destiny, change forever.

We can’t shift our consciousness by reading about how to shift our consciousness. Or reading or studying about how or what we should be or shouldn’t be.

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

ur own, personal, powerful experiences are what creates permanent shifts in perception, not cramming our heads with words. And when these shifts authentically take place, we know it, for now we see clearl

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

, and what we had previously thought to be truth now becomes just so many words, because now we know for sure in our hearts. And our actions reveal it.

So, should we wait for a bus to hit us before we im

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

Following aspects would a

prove our lives, or should we become proactive and embark upon a pursuit of the deepest of human experiences, that mysterious state of mind coveted by prophets and seers throughout the ages? But how do we

dd to the challenges in developing combination products:

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

do it? How will it change us? Are we capable of doing it at all? And where can we find someone we can trust to teach us?

Unfortunately, teachers ruin the student, as well as themselves, because teachers

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

ecome caught up in imparting second or third-hand knowledge, wasting their time and their students’ time. This is fine if you need to gain mundane knowledge to make your way in the world, but if you truly

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

seek that which you have not yet found, (that which is rare for anybody to find), then the teacher can only be you . . . and the path can only be your own.

Direct experience is all that will satisfy you

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

ow; you must know for yourself what those liberating shifts in consciousness are that free you from all conflict. You look for nothing less than the real deal this time, and the real deal is . . . freedom

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

Professional from academic institutions, pharmaceutical industries, health care indust

– freedom from fear, freedom from authority outside of yourself, and freedom from your self.

The teacher must be ultimately no one but you. You are the one who must make it happen. Someone who has been t

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

ere before can offer a road map of the mountains and valleys they have trekked, indicating scenic spots as well as dangers, but you are now the traveler who must make his or her path through the forest. Y

.

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

u must create that shift of consciousness within yourself. If you simply read books as you have in the past, all you gain are facts, which are nothing more than a map. The profound answers you seek lie no

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

Companies that provide selfless information through particip

in books and lectures, but within yourself, where they have always been, patiently awaiting your consciousness to shift since the beginning of time.

Copyright © E. Raymond Rock 2007. All rights reserved

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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HMO stands for “Health-Maintenance Organization.” HMOs provide members with comprehensive care by healthcare professionals under contract, or by their own group practice.

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