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During the holiday season, and in business generally, we ca

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

n hear the pursuit of more: more money, more customers, mor

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

Examples of combination products may in

profits, more food, more clothing, more friends, more time

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

, more more.

When is more, enough? Do you have enough air

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

o breathe and food to eat? Enough space to live in and busi

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

Combination pro

ness to keep you busy for a while?

If you are reading this

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

now, you’ve surely got enough in your life to give yourself

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

an occasional rest, a break, a moment out of the persisten

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

quest for more…a chance to really enjoy what you already h

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

ave, which most of the time is quite enough.

This is not a

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

call to discard ambition or quell your quest for greater go

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

Following aspects would a

als. Rather, this is an invitation to enjoy a moment of rel

dd to the challenges in developing combination products:

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

xation where you are, calm in all that is, comfortable in a

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

ll you have, and grateful for the chance just to be here.

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

hat’s enough.

YOU MAY USE THIS ARTICLE IN YOUR FREE NEWSLE

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

TTER OR YOUR WEB SITE as long as you include this complet

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

Professional from academic institutions, pharmaceutical industries, health care indust

statement:

Copyright, Ron Kaufman. Used with permission.

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

Ron Kaufman is an internationally acclaimed educator for

.

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

uality service. He is author of the bestselling series "U

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

Companies that provide selfless information through particip

P Your Service!" and founder of "UP Your Service College.

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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