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Pay attention…focus…concentrate…prioritize…Easy to say but hard to do when so much is vying for your attention. What makes it

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

so hard to master these basic concepts?

Have you ever stopped to consider how much is fighting for your attention? Just picture for a moment:

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

Examples of combination products may in

Opening a website page --pop-up dialogs springing into view --boxes of ads and comments lining the sides of the pages --multiple colo

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

rs screaming out at you

Driving down the freeway

--billboards, high and low, --radio ads interrupting the

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

traffic report --your cellphone ringing

Watching your favorite television show

--Floating announcements advertising

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

Combination pro

other shows --Information strips scrolling weather updates and political announcements All of that is before you get to the office. The frenetic pace c

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

ontinues as deadlines loom and you cope with constant interruptions. End results are often that you have to work late, bring work home with you, or come

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

in early. You become tired and stressed, which makes it even more difficult to focus.

I read of one person who would leave the office and go sit in hi

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

s car when he had papers he needed to absorb and make a decision on. It was simply impossible for him to concentrate in the office.

Almost everyone tod

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

ay is exhibiting symptoms similar to those relating to an ADD diagnosis. Whether you are suffering from Modern Life Syndrome or ADD, you need to employ

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

processes that will limit distractions and increase your productivity. Strategies are similar:

1. Prioritize your work before you leave the office each

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

Following aspects would a

evening. It will eliminate that 20-30 minutes of sorting through stacks before you get started the next day. The morning is most people’s prime energy

dd to the challenges in developing combination products:

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

time, and you do not want to waste those blocks of time trying to decide where you should be focusing.

2. Plan a solid block of time with limited inter

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

ruptions. Put this on your calendar so that you will stick to it. Use that time for your most important, focused work.

3. Track what causes the interru

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

ptions. Do this for two weeks so that you can begin to recognize patterns. Who interrupts you? How often? What times of day? Once you find the routines,

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

you can begin to eliminate some of these distractions.

4. Do not let email control your day. It is too easy to become absorbed in your overflowing inb

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

Professional from academic institutions, pharmaceutical industries, health care indust

ox and lose track of time. Set up specific blocks of time when you will focus on email alone.

If you do not stop now to make changes, the result can be

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

a major overload because of constant stress. Stress is responsible for many of our illnesses, from colds and flu to heart conditions. When you are not

.

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

willing to step back and make adjustments, you may wind up with a situation over which you no longer have any control.

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

Companies that provide selfless information through particip

="_blank">Wouldn’t it be nicer to choose your priorities and be more productive in the process, before the ability to choose is taken away from you?

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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