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“It is only by following your deepest instinct that you can lead a rich life, and if you let your fear of consequence prevent

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

you from following your deepest instinct, then your life will be safe, expedient and thin.”
Katherine Butler Hathaway

We

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

Examples of combination products may in

all have heard that animal instincts are the strongest. The natural instinct in these creatures is their behavior that allows

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

them to react quickly. Dogs have very strong instinct that makes them realize a lot of shortcomings beforehand. Although very

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

few human have that strong instinct yet all of us have a basic instinct that tell us inwardly what is correct and what one sho

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

Combination pro

uld do if certain things are going wrong. We do not learn about these instincts but it is something naturally gifted. We only

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

ave to make an effort to listen to our inner voice.

“There is no instinct like that of the heart”. Lord Byron has said it rig

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

ht. The true instincts in a man are the voice of his or her heart. People should do what the heart tells them to do. When thin

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

gs are not going right it is the heart that tells us to move forward to resolve the problems.

Listen to your inner voice, the

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

voice that is true and honest and helps to take right decisions. Most of the times when people face tribulations in life or if

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

something is not going smoothly in life, people let things go as they are. They do not make an effort to find out the problem

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

Following aspects would a

and thing that the difficulties will be resolved with the passage of time. And it is here where many couples make a mistake.

dd to the challenges in developing combination products:

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

ften when couples are going through bad period they feel it is a part of life and will be settled on its own. But this is not

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

the case always. Most of the times things need to be solved out otherwise situations turn out to be worse. People should liste

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

n to their instincts and should work out the problem together. At times when things are going wrong something from inside make

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

us feel that the problem is caused by such and such reason. This feeling is so strong that no other reason comes to mind apar

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

Professional from academic institutions, pharmaceutical industries, health care indust

t from that particular reason. But at it is just one thought that comes to the mind and vanishes. It too could be the indicati

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

on of your inner instinct.

Whatever the indication individuals should not ignore these inner voices and try to solve the diff

.

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

culty along with their mate with the help of their inner instinct.

In conclusion it can be said what Oprah Winfrey states, “F

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

Companies that provide selfless information through particip

ollow your instincts. That's where true wisdom manifests itself.” You make the right decisions when you follow your instincts

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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