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It is maybe... No, it is too early to talk about the end of a hype when the hype has not really started yet. In this

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

way this contribution is not really client focused. Never row against the flow...But it can do no harm either.

Not

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

Examples of combination products may in

only some stock exchange experience will teach us that expectations are sometimes inflated. For some trends it could

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

take years before they grow into a real hype. But then, when the expectations are no longer met you should be prepar

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

d... For those who are in the Article production business. The threat comes from on aspect which is easily underesti

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

Combination pro

mated.

A Hype Cycle is a graphic representation of the maturity, adoption and business application of specific t

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

chnologies. Since 1995, Gartner has used Hype Cycles to characterize the over-enthusiasm or "hype" and subsequent di

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

appointment that typically happens with the introduction of new technologies. (http://www.gartner.com/pages/sto

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

y.php.id.8795.s.8.jsp)

Such a cycle consists of five phases;

1. "Technology Trigger"
2. "Peak

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

of Inflated Expectations"

3. "Trough of Disillusionment"

4. "Slope of Enlightenment"

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

>5. "Plateau of Productivity"

An important lesson of Gartner is that all that is new is fancy and gets (p

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

Following aspects would a

ess) support. Then, when the enthusiasm is over, the disappointments follows and support (commitment) falls back. An

dd to the challenges in developing combination products:

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

this commitment is needed for projects to succeed.

The project in this case could be: article production and syndi

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

cation. If you think that the hype cycle is only for introduction of new technology, you could use the wisdom of the

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

stock-exchange; there too the stock prices are often inflated because of unreal expectations. Disappointment will al

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

o follow.

Now what could lead to such disappointment?

Quality.

What is very likely to happen is that the quality

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

Professional from academic institutions, pharmaceutical industries, health care indust

f the article production gets hurt by the demands of quantity. We want more and we do no longer bother about the qua

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

lity. Quality is in danger when quantity gets all the freedom.

Interesting in this context is the economic law of G

.

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

esham:

“bad money drives out good money”

The “universal” reach of this law is debated. Yet for those who think thi

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

Companies that provide selfless information through particip

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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Advice You - Be Aware of The Article Production Hype

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