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Are you always finding yourself helpless? Have you tried every possible method for fixing your problems yet found that there is no way out? do you think that you are a helpless person? If you have experienced the

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

se feelings before then I am sorry to tell you that you have been fooled, you weren’t born helpless, you just learned how to become helpless.

An experiment was carried out on a number of dogs by subjecting them

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

Examples of combination products may in

to electric shocks while provding them with a switch that they can use to stop the electric current from flowing into their bodies, but for a group of dogs the switch were set not to work even if it was pushed. 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.

fter the experiment ended some of the dogs who weren’t able to stop the electric current developed symptoms that are similar to clinical depression symptoms, or to put it in another way these dogs learned how to

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

be helpless.

You weren’t Born Helpless

Have you ever tried to notice how a small child tries over and over to do the same thing without getting bored? have You ever met a person who can’t walk now because he lo

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

Combination pro

st hope as a kid and didn’t try to stand on his both feet while being a child? Why don’t these kids stop trying and why do adults stop? Because through their life experience some adults tend to develop a new abil

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

ity, the ability to feel helpless!!

How did i learn to become Helpless?

I have met many people who used to recover from setbacks within few days, and then few years later those people became helpless and depres

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

sed. When I talked to one of them I discovered that he was totally convinced that there is no way out and that he is really beaten up this time. But what happened? How come did these warriors who used to recover

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

when others used to lose hope lose their strength? The following is what happened to them:

* Learned Helplessness and being Helpless: If you faced a big problem in your life you are likely to take one of these 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

ctions, 1) keep trying until you solve it 2) keep trying while losing hope, 3) lose hope and stop trying. If you did the second or the third action then you are more likely to learn how to become a helpless perso

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

n. You prevent this from happening by never quitting anything midway unless you have no other option, the more you quit the more you will record new failures in your history and the more likely you will learn how

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

Following aspects would a

to become helpless.

* Learned Helplessness and Subconscious Mind Programming:At the time of crisis you may become highly sensitive and receptive to critical comments that you recieve from the people surrounding

dd to the challenges in developing combination products:

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

you, if your friends were helpless too they will keep transferring their experience to you until you will learn how to become helpless. The solution is simple, try to choose successful friends, I know that this

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

may be something that is out of control but at least put this new parameter into consideration while expanding your relations.

* Media and Learned Helplessness: The song “My Immortal” is considered a perfect exa

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

mple for teaching you how to become helpless, the choice of words simply programs you to learn how to be broken. Don’t underestimate the effect of the music you listen to on your personality, its impact is far bi

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

gger than you could imagine. (see the psychological effect of songs for more information

Learned Depression and Learned Helplessness

I have met people who used not to get depressed whatever happens to them and

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

Professional from academic institutions, pharmaceutical industries, health care indust

on speaking to one of them few years later I found him depressed. Just as helplessness can be learned, depression can be learned too simply because in many cases depression is nothing more but being convinced tha

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

t you are helpless. This emotional pain you are currently experiencing as a result of your depression may be nothing more than a false belief about your ability to take an action!!

Final Words

Don’t let life fo

.

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

ol you, don’t learn how to become helpless because you have failed once or twice Whatever the situation you are facing force your way out without feeling helpless, and whenever you feel like being broken just re

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

Companies that provide selfless information through particip

mind yourself of the fact that helplessness is learned and that it’s not something that you were born with, And remember, just as you learned helplessness by practicing it you can unlearn it by not practicing it.

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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