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Just Other Articles - Expect to Get! A Fail Safe Formula
In school we learn a variety of math formulas. We learn how to convert temperatures from Fahrenheit to Celsius; we learn how to calculate the area of a triangle and much more. The beauty of these formulas is the ce
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
rtainty they provide. We know that if we know the formula and have the correct inputs, we can compute the correct answer. Presumably, as adults we are using these formulas to solve a problem and move us towards som
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ething we desire.
People ask me about unleashing their potential – how to do it, what steps to take and more. Because of this recurring and important question I have worked to distill part of the answer into a form
People ask me about unleashing their potential – how to do it, what steps to take and more. Because of this recurring and important question I have worked to distill part of the answer into a form
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
la. This formula will help us because if we can identify the inputs and use the formula correctly, we can improve our performance, and provide greater service to others, as we reach towards our potential.
The Input
The Input
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s
The inputs to this formula are:
Expectations – Those things we expect of ourselves.
Beliefs – What we believe to be true about ourselves, our skills, abilities and potential; and our world.
Actions – the behavi
The inputs to this formula are:
Expectations – Those things we expect of ourselves.
Beliefs – What we believe to be true about ourselves, our skills, abilities and potential; and our world.
Actions – the behavi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ors we exhibit and the things we do.
Reality – the results or endpoint of the efforts.
The Formula
The formula goes like this: Expectations create beliefs. Beliefs create actions. Actions create realities.
Per
Reality – the results or endpoint of the efforts.
The Formula
The formula goes like this: Expectations create beliefs. Beliefs create actions. Actions create realities.
Per
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
aps you will want to remember this formula as: EBA=R
As written, it looks like it is a formula that uses multiplication. In a way it does – if you have a zero in any of the first three inputs, there will be no chan
As written, it looks like it is a formula that uses multiplication. In a way it does – if you have a zero in any of the first three inputs, there will be no chan
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
ge to your reality (or results). However as we all learned in math class, in multiplication you can complete the formula by multiplying the factors in any order. In our formula it all starts with expectations, in o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ther words, the multiplication must be done in order to make sense.
Anything Else?
Before I go any further, let me say that this formula assumes a desire to reach for new results – without desire to tap into or dis
Anything Else?
Before I go any further, let me say that this formula assumes a desire to reach for new results – without desire to tap into or dis
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
over our potential the formula doesn’t even apply.
But I know, because you are reading this article, you have that desire, so we can move onward …
An Example
Let’s say that I see a friend and they tell me they jus
But I know, because you are reading this article, you have that desire, so we can move onward …
An Example
Let’s say that I see a friend and they tell me they jus
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t ran a 10K race. I tell myself, I could do that – I expect that I am capable of running a 10K race. The more I think about this race, telling myself that I could do that, the more I believe my assertions. My beli
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ef and expectations begin to create an excitement which leads me to start running. Even when I realize how out of shape I am, my expectation and belief pushes me to run a little more every day.
Along with my runnin
Along with my runnin
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
, I do some other things – I ask other runners about their preparation plans. I pick up a book at the store or library to learn more about running technique. I ask the knowledgeable sales person in the store about
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
the proper shoes to buy.
Expectations and belief fueled action, and now the action is reinforcing the belief as well. My running expectation has snowballed! I build a plan to compete in a specific 10K race and the
Expectations and belief fueled action, and now the action is reinforcing the belief as well. My running expectation has snowballed! I build a plan to compete in a specific 10K race and the
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
n complete it.
At the start of this process, when I put this expectation into my mind, my body wasn’t capable of making the 10K – maybe it wasn’t capable of making it to the mailbox! But the potential was there lat
At the start of this process, when I put this expectation into my mind, my body wasn’t capable of making the 10K – maybe it wasn’t capable of making it to the mailbox! But the potential was there lat
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
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
nt waiting to be unleashed. I unleashed the potential by having positive expectations which created belief which fueled action which led to me crossing the finish line of the 10K race. EBA=R.
Be Aware …
It is imp
Be Aware …
It is imp
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ortant to note that this formula works for any expectation - positive and uplifting, or negative and cynical, so be careful what you expect!
It is equally important to recognize that you can use the formula to help
It is equally important to recognize that you can use the formula to help
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
others unleash their potential as well. Your positive expectations and encouragement of them will help generate their own expectations, which allow the formula to work.
In Closing
If we fervently expect something
In Closing
If we fervently expect something
.
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
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
ill happen, then we develop a belief, a true expectancy about that event or circumstance. When we believe, we will take action on those beliefs. And the right action, as we all know is required to create new results
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
. EBA=R.
Use this formula for yourself. Set your expectations higher! Reinforce those expectations by thinking about them regularly. If you couple that with true belief, you are on your way.
Why not start today
Use this formula for yourself. Set your expectations higher! Reinforce those expectations by thinking about them regularly. If you couple that with true belief, you are on your way.
Why not start today
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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