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Emergence Personality Theory sees personality as comprised of a nested set, and subsets, of fractals. A nested set of recognizable patterns which always repeat dif

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

ferently. Moreover, the theory describes these nested fractals as organizing around a single strange attractor; the sequence of three events we experience in 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

moment in which we physically separate from our mothers.

I call this event, the Birth Separation Moment. Not that what happens prior this event has no affect on pers

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

onality. It is just that before this moment, everything we experience, we experience with someone. Not as two separate beings but rather as two beings that are one be

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

ing. In the most intimate human relationship we will ever know.

Literally then, before birth we live in a kind of experiential Garden of Eden. In a marriage of soul

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

Combination pro

mates. In a suspended state of seemingly permanent togetherness. In this state, we face whatever life throws at us with an ever present partner in an ideal kind of in

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

timacy. Connection at its finest. At least for us humans.

Am I being too philosophical? Sorry. What I am saying here is, before we physically separate from our mothe

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

rs, we live life as an ongoing "co experience." As if we are joined to another at the psycho spiritual hip, so to speak. In effect, it is as if we were conceived marr

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

ied. Can you imagine? We physically occupied the same space and time as another human being with not a single moment of having to face our needs alone. Not a one.

Hu

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

ngry? We ate the same food.

Tired? We slept the same sleep.

Cold or hot? We shared the same blanket. And felt the same sounds. And suffered the same illnesses.

My

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

point? Before we experienced the Birth Separation Moment, we had yet to know what it was like to face a need alone. Not even for a single moment. Not even for the bli

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

Following aspects would a

nk of an eye.

Then it happened. With no forewarning (at least none baby humans could possibly grasp), we were forcibly expelled from this Eden-like state of perpetua

dd to the challenges in developing combination products:

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

l togetherness. Within seconds then, and for the first time, we had to face life alone. With no instructions and no time outs. Needy. Scared. Blind. And hungry.

Unde

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

rlying this event is the simple sequence of three experiential states from which all human personality forms. This sequence roughly comprises our three most personal

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

human experiences; [1] the experience of connection (to others and to our world), [2] the experience of aloneness (the experience of disconnecting from

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

these connections), and [3] the experience of need (our natural response to these disconnections).

What makes this sequence so significant is that it then bec

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

Professional from academic institutions, pharmaceutical industries, health care indust

omes the experiential pattern for any and all events which injure us, regardless of the nature of the symptoms; connection, disconnection, and neediness.

In a

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

very real way then, we could say that all human injury, including everything we explore in talk therapy, is a reliving of this Birth Separation Moment fractal patter

.

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

n; connection, disconnection, and neediness. Admittedly, there is a lot to discuss here. Including why the nesting numbers begin with ten and not one. Know we'll talk

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

Companies that provide selfless information through particip

a lot more about this fractal sequence in coming articles. Including why experiencing it injures us as well as how it reveals the pattern beneath all healing events.

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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