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We often think of a “paranoid” as being what someone is, more often than not however, it would be more accurate to use this label to describe one’s patterned style of thinking. Learning to understand the structure of such thought patterns can be very beneficial, not only for those who tend to engage in this manner of processing information, but for those who have frequent cont

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

act with those who are producing thoughts and feelings that result from this disrupting flow of data.

Before we dive in though, it’s important to understand what is referred to as logical levels, when referring to our thoughts. Albert Einstein once said that “a problem cannot be solved on the same level that it exists” and this is exactly what he was referring to. I might add

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

Examples of combination products may in

that a less than useful utilization of logical levels can also take a problem that doesn’t exist, and create “thought demons” that throw your nervous system into a tizzy.

Logical levels might best be described as aboutness; using the “ladder” metaphor, when you have a thought about a previous thought, you have just “gone up” a logical level. Although various people will agre

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

e or disagree with the following, my definition of a logical level is the first level of thinking that involves aboutness, and that no longer relies solely on raw sensory input. What is sensory input? If you see a handgun in the middle of your living room floor upon entering you home, sensory input is nothing more than the visual information you register when first seeing the

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

gun. Further sensory data might consist of the coolness of the metal or the weight of the gun as you lift it, or, if you pull back the hammer, the sensory input may also be comprised of a sound. This is referred to by psychologist Michael Hall, as primary awareness.

Enter the first logical level; you now think to yourself, “What is this gun doing in my house?” This thought ab

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

Combination pro

out what your senses have detected, generates both a search for meaning, as evidenced by either the question, “ What is this gun doing here?” or the simple recognition, “ There’s a gun in my house.” You have now had thoughts about the gun.

Jumping to the second logical level, you we now have the opportunity to categorize the gun. This is where we find a huge discrepancy from

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

one person to the next, in the meanings they will assign to the gun. From this logical level, someone with a teenaged son might think, “That’s scary; my son is planning to kill himself!” Yet another person may simply think, “ That kids at it again, he’s always buying something and leaving it laying around…he’s so irresponsible” While yet another might think, “ Someone has brok

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

en into the house, and there’s been a fight here in the living room….They’ve kidnapped my son!” As you may have already surmised, the available meanings we could assign to what our senses have detected are only limited by our imagination, which is to say, it’s limitless.

Now, even when a less than useful meaning has been assigned on logical level two, about what we have seen,

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

heard, smelled, tasted, or felt when we walked into the room, the intensity of our response/reaction in terms of our behavior and feelings, will largely hinge upon what occurs on the third logical level.

The level of certainty a person has about the thoughts they had on the second logical level are all important. Please note that the thoughts on this level are even further a

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

way from the level of primary information than the thoughts on level two. Also, notice that the thoughts on level two may very well make up what the person is calling the problem. The man or woman that thinks, “Cool, John has used his money wisely, and bought something that will hold value, instead of spending it on drugs” will not be experiencing a “problem” about what they h

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

ave detected. The same cannot be said of the person who thinks, “My son is thinking of killing himself.” The “problem” this person will experience, will have been initially generated by their thoughts about the gun, or what it means.

If, after having assigned a meaning on level two, a person has feelings of certainty about those thoughts, they will have strengthened and solid

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

Following aspects would a

ified the level two thoughts and feelings, neurologically speaking.

The number of times we can reflect on something, or, the number of logical levels we can ascend regarding some sensory based event, is unlimited. Therefore, it is crucial that we understand this: each new or “higher” logical level thought, governs, modifies and alters all that are below it. This understanding

dd to the challenges in developing combination products:

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

offers tremendous insight then, to the logical level we might work from when wanting to create a change in ourselves or others.

If I am certain that the gun means my son is planning to commit suicide, I allow no other thoughts in at that point, and if someone attempts to persuade me otherwise, I will vehemently defend my position.

If however, my sons possible suicide plot e

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

nters my mind, but my thoughts and feelings on the third logical level are a bit shaky, or uncertain, my mind will still entertain other possible explanations, and I’ll be less likely to begin acting on any certain thought or explanation until I have investigated the matter more fully. This by the way is truly a mark of a healthy style of thinking.

How can we break out of thi

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

s loop, or assist another to escape the trap of certainty, when the power of our affirmation is producing “crazy” like or unfounded behavior? For this we can often rely on the “magic” of paradox. Paradox “jams” things up a bit, and quite paradoxically then, frees our thinking and behaving.

There is an ancient story that peeved theologians and philosophers, due to the fact tha

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

t it was seemingly impossible to work with. According to the story, the devil once asked God to create a rock so large that even God himself couldn’t lift it. If God could not lift the rock, he would no longer be omnipotent; if he could lift it, that would only mean he was unable to make one big enough that he could not lift it. How can we use the structure of paradox then?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Richard Bandler, co-creator of NLP once used an example similar to the one below. Although I’m not sure what the limitation of the person he was working with was, for our example, let’s just assume that the person was convinced that they were “worthless” and that no one loved them.

Bandler: Are you sure of that?
Client: Yes.
Bandler: Are you sure you’re sure?
C

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

lient: Are you sure enough to be UNSURE?

Notice that after he has asked this question, no matter what answer they give him, they have just “loosened” the “grip” of the thoughts and beliefs that had been limiting their thinking so tightly. If they say, “Yes, I’m sure enough to be unsure” they have accepted that they are somewhat unsure. If they say, “No, I’m not sure enough to

.

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

be unsure” They have expressed doubt, and have once again, accepted that they are somewhat unsure.

So let me ask you, what are you sure enough of to be unsure about? Or, perhaps there’s something that you’re not sure enough about to be unsure of. Think deeply on this, I’m sure you’ll find it to be as liberating as I have, or the countless clients I have used this with to loo

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

Companies that provide selfless information through particip

sen their thoughts.

I’ll write more on this later, but this should be enough to get you “thinkin.” Logical levels can at first, be a bit challenging to grasp, but once you have been able to see clearly, just how you have been using this structure, you soon be orchestrating your thinking, and find that Einstein was right.

© Copyright, 2007- Vincent Harris- 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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