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There are many factors that influence the decision process when managing (change). The amount of

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

participation around an issue is one. The choice in favour a gradual or radical pace of the pro

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

Examples of combination products may in

ess is another. This topic is about whether you can control the problem with a technical and or

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

conomical solution or that the solution is very much influenced by a social and political enviro

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

nment.

To define the quality of a solution is a normative practice. Yet any thorough technical

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

Combination pro

r economical solution for a problem would normally qualify to obtain a quality norm. But what if

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

the solution is the result of a social or political outcome?

Remember the issue with the dispos

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

al of the Brent Spar ten years ago. This was an oil platform which economic life had ended. The

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

nitial approach to solve the storage of this platform (the problem) was to let it sink in the se

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

. Technically and economically the best solution. Yet, this became a public issue and the Oil Co

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

pany needed to search for another solution (the dismantling of the platform). This was a social

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

Following aspects would a

and political influenced solution.

Management in (large) companies involves often a lot of poli

dd to the challenges in developing combination products:

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

ics. This is the case when employees are (negatively) affected, for example when dealing with ou

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

sourcing. The benefits of outsourcing could be measured by economic and accounting measures. Thi

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

s is purely a question of numbers. On the other hand, there are quality elements that are not ea

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

y to measure. “Economists know the price about everything, but the value of nothing,” is often u

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

Professional from academic institutions, pharmaceutical industries, health care indust

tered in this context.

On much simpler scale this dilemma occurs in a variety of issues where a

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

manager need to find a solution. You should know by experience which issues require a technical

.

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

approach and which issue are political.

Try to leave politics out as much as possible, but pay

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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