Main Subject - Business

It is said that who you are in life will be who you are in business (even a work

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

from home business) and vise-versa. If you are someone who is respected in life a

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

Examples of combination products may in

d considered a person of stature, you will also be that in your work from home bu

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

siness. Just the same with money….a poor man who inherits a million dollars will

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

nce again be a poor man, unless he first becomes the millionaire, and then inheri

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

Combination pro

ts his millions. Who you are without money is who you will be with money, just ri

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

her.

In business, posture and integrity are everything. How someone views you as

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

a leader, a businessman, a mentor, a merchant, and a person will directly reflec

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

on your success. Now, I have seem some pretty shady people go into business and

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

do really well at first. I attribute that to good planning. But as time goes on t

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

at persons business will eventually decay away and fall out from underneath him.

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

Following aspects would a

have seen it over and over. In my book, the honest, fair, and just will always p

dd to the challenges in developing combination products:

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

revail.

Always operate your business out of integrity at all costs, whether in y

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

ur favor or not. Integrity is basically your ability or drive to “do the right th

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

ing” in-spite of the ethical or personal distress it may cause. When faced with d

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

cisions, always do what is ethical. If and when you do this, you will find that y

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

Professional from academic institutions, pharmaceutical industries, health care indust

our business will flourish. Others will trust you, confide in you, and depend on

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

ou to always act out of integrity. Being a leader means leading in your life as w

.

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

ell. You must not only lead in business and success, but you must be an example o

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

Companies that provide selfless information through particip

ethics and morality. Live in integrity not just sometimes, but ATT, all the time

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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