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There are many activities that oppose to change initiatives. Maintenance is one you proba

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

bly wouldn’t reckon to fit the profile, yet it is a very powerful element fighting change

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

Examples of combination products may in

propositions. And possible without the intention of doing any harm.

Maintenance is the

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

group of activities that are used to gradually upgrade... systems, buildings, cars and ju

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

st everything else that is durable. Even knowledge can or should be maintained.

A busine

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

Combination pro

ss example. There is this information system. It has been designed eight years ago and al

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

l consecutive years the system has thoroughly been maintained. New functionality has been

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

added according to extra requirement that were necessary to handle the latest development

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

s. Due to this conscientious maintenance the system could survive years with the continuo

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

us launching of new technology. Voices in the same company to build or even buy a new sys

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

tem have been parried and the maintenance budget increases even more.

Think about the op

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

Following aspects would a

posite of a situation where there is a complete absence of maintenance. House windows are

dd to the challenges in developing combination products:

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

a good example. When the paint peels off over time, and the wooden structure erodes, the

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

window is due to replacement. And often maintenance-free-material like polyester or othe

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

synthetics replaces the traditional windows: “Hasta la vista windows!”

But serious, “ma

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

intenance” and “change” are fierce competitors. They form a relation of which you should

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

Professional from academic institutions, pharmaceutical industries, health care indust

be aware but which also provides opportunities. The first thing to do when planning a cha

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

nge is to stop all maintenance. Another thing is to check the horizon when preparing 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

an investment. A more innovative attitude requires a short-term focus. High investments i

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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