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It's hard to explain to people what I do. This happens to many people. While it doesn't happen everyday

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

, knowledge changes our outlook and direction. What we do could change tomorrow. We know what we do, bu

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

Examples of combination products may in

how do we tell other people so they appreciate who and what we are?

I've got a friend who's an attorn

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

y. He's also a Certified Public Accountant. Being an attorney and being a CPA are just two of the title

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

he has collected for what he really does. He's a real estate consultant, who works with people who cre

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

Combination pro

te real estate developments.

Jean Butler, the freckled beauty from Riverdance, grew up taking d

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

nce lessons. She says she was too tall and her feet where too big for ballet, but still she took classe

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

s. People would ask her what she did, but she couldn't really answer. The answer was Irish Dancing, but

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

at the time, no one else really knew what that was. Jean didn't know how to explain that to casual ques

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

ioning. She debuted with The Chieftains at 17 and once Riverdance took the world by storm in 199

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

, everyone finally knew what Jean did.

But in reality it didn't help. Jean had ambitions. She didn't j

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

Following aspects would a

st want to dance, she also wanted to act. Although she co-starred in The Brylcreem Boys, she aud

dd to the challenges in developing combination products:

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

tioned for other films and didn't win roles. "I found myself cemented in a box with the word `dancer' w

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

itten across the top of it," she confessed. "I'd get all these scripts for the redheaded Irish girl wh

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

o can jig, and that's a bit frustrating."

Take my best friend, Randy, you could say he's a life insura

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

ce salesman, but he would argue that he's a financial consultant offering annuities, salary protection,

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

Professional from academic institutions, pharmaceutical industries, health care indust

health coverage, and mutual funds for investing.

I think what's happening is that we're all awakening

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

o a new reality that throws off limitations and let's us chose more widely who and what we want to be.

.

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

t's a great big world. We truly can define what we want to be . . . if we can just decide what it is th

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

Companies that provide selfless information through particip

t we want to be.

I know what I am today, but explaining that to someone else gets a little complicated

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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