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Use your time for problems that are truly important.

Hard as it may be to walk away once you’

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

re aware of it, just because a problem is there doesn’t mean you have to solve it. Ask yourself and y

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

Examples of combination products may in

ur colleagues, “What will happen if we don’t solve this problem?” If the answer is, “not much,” then

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

turn your attention to something more important. If you don’t know what will happen, find out before

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

ou undertake a problem-solving project. It should be clear to you and everyone else involved that the

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

Combination pro

problem is worth the effort—and expense—to fix it.

Quantify the cost of the problem quickly, but as

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

realistically as you can. Include lost opportunity costs as well as real expenses such as staff time

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

o deal with the problem, travel expenses, etc. Use actual costs where you can; estimate where you can

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

t. Then guesstimate what it will cost to analyze and fix it. Write your analysis down, stating all yo

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

ur assumptions explicitly. Get a colleague to verify that your assumptions and estimates are reasonab

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

e. Start with a rough “order of magnitude” estimate. That may be enough to answer the question of whe

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

Following aspects would a

her you should proceed. If it’s not clear, especially if the cost to solve it will be high, do a more

dd to the challenges in developing combination products:

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

careful analysis.

If it will cost more to fix than to live with the problem, or if the number is ev

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

n close, perhaps your resources (time, people, money) are better spent on other projects. If you deci

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

e to proceed anyway, you can do so with a better understanding of what you’re undertaking. On the oth

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

er hand, if you can demonstrate that the cost of the problem is much higher than the cost of solving

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

Professional from academic institutions, pharmaceutical industries, health care indust

t, using estimates based on reasonable assumptions, it will generally be much easier to get the resou

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

ces you need. You can use your written analysis as a sales tool to help win support for your decision

.

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

to proceed or not.

We have to learn to distinguish those things that are truly important from th

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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