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As I walked through a major pharmacy chain store the other day, I stopped as I walked past the massive section of shelves that contained the seemingly endless supply of various lotions, liniments, and creams for arthritis, fibromyalgia and other types of physical pain.

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

Having been diagnosed with fibromyalgia in 1997, I remember all too well the constant search for the latest, greatest, miracle pain relieving product; the one that would eliminate the need for any effort on my part to improve my day to day comfort levels. Without hes

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

Examples of combination products may in

itation, I’ll tell you I probably purchased every product that was available that promised to banish the pain from the knotted and twisted muscles in my neck, back and shoulders, between 1996 and 1998. But something happened in 1998 that would forever change my life.

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

In December of 98, I enrolled in a hypnosis certification course, at the Hypnosis Training Institute of San Diego, in San Diego California. I had always been fascinated with the human mind, and different forms of accelerated learning and personal development, but thi

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

was a hands on training, with “real time” feedback, and experts in the area of hypnosis and NLP watching and evaluating our every move; it was an extremely intensive training….and I absolutely loved it.

After becoming a Board Certified Hypnotherapist, and Master Hypn

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

Combination pro

otist, with an initial specialization in pain and healing in February of 1999, I started a journey that is still running full blast some 8 years later. When I initially enrolled in the hypnosis program, my goal was to simply learn the secrets of unlocking the part of m

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

y mind that would allow me to eliminate, regulate, or modify my pain and discomfort. Little did I know at the time, that I would eventually utilize this knowledge to assist people around the world to significantly enhance the quality of their lives.

Perhaps the most u

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

eful concept that I incorporate in my protocol for pain relief, is that of chronic pain consisting of a triad; 1/3 remembered pain, 1/3 actual pain, and 1/3 anticipated pain. Each third contributes to the overall gestalt known as “constant” pain. Understandably, this m

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

odel is particularly useful, as 2/3’s of the whole don’t even exist outside of the life that we give them through focus of our attention.

When one is able to banish thoughts of yesterday’s pain, or last weeks, or last months, and stop the frequent “replays” of past mo

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

ments of pain, they will have successfully and effectively dealt with 1/3 of the discomfort. Likewise, when a person learns how to derail the old patterns of worrying about or anticipating how much they might hurt later today, or tomorrow, or at any other time in the f

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

ture, they will have eradicated yet another 1/3 of the pain, for a total reduction of 2/3’s of the previous “pain.”

Before you dismiss this as nonsense, let’s take a look at this from a neurological perspective that nearly everyone has experienced countless time alrea

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

Following aspects would a

dy. I don’t know if realize this, but did you know that if someone had grown up since birth, and never experienced any form of pain, however slight it might be, they would not have the neurological “signatures” of pain in their neurology to be able to negatively react

dd to the challenges in developing combination products:

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

or “wince” when observing someone else having pain inflicted upon them.

Since most of us don’t have a life history void of the experiences of pain or injury, we can identify with much of what we see others endure. Watching others in pain actually causes us to access n

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

eurological memories of the pain we have experienced, thus bringing aspects of that discomfort into the present, even when no actual stimuli for the pain exists.

The directors of horror movies rely on this mechanism to make us scream and contort our facial expressions

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

as we watch the poor victim on screen get a screwdriver stabbed into their eye……..did you feel that? While you’ve probably been fortunate enough to escape the screwdriver in the eye dilemma, you have most likely felt the pain of inadvertently poking yourself in the eye

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

; you have a memory of discomforting experiences with your eye, and that’s enough to cause you to squirm a little bit, just from reading about alternative uses for screwdrivers.

When I was in the “throes” of my fibromyalgia years ago, I would wake up each day, already

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

Professional from academic institutions, pharmaceutical industries, health care indust

knowing (anticipating future pain) how bad I would feel after I got out of bed. I “knew” this because that’s how I had felt (remembering past pain) yesterday, and countless days prior to this particular morning. Interestingly enough, both anticipating pain, and rememb

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

ring past pain, both contribute in a powerful way to the present moment. In short, when we learn to experience only what is present now, and stop amplifying that experience with the misuse of the “past” and the “future” we find that we have already transformed our real

.

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

ity.

Once you have successfully eliminated the needless intrusions of the past and the future on your present moments, you can then enjoy shifting the actual discomfort of now, with other leading edge strategies for altering the less than comfortable signals of your n

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

Companies that provide selfless information through particip

ervous system.

I know in my heart that anyone who is willing to take this concept, and begin to apply it to their own experience with chronic pain will find it to be as instrumental in finding relief as those I have been able to share it with personally over the years

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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