Main Subject - Business

On the eve of his fourth birthday, my son could hardly contain his excitement as we tucked him in for bed. The following morning, the birthday boy jumped out of bed and ran downs

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

tairs to look in the bathroom mirror. His giant smile contorted itself into a confused grin as he looked himself over in the mirror.

“I don’t look any different now that I’m fou

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

Examples of combination products may in

,” my son said to me without taking his eyes off the mirror. His emotional blend of innocence and confusion made me smile as I shook my head with paternal pride.

Sure, it’s cute

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

when a four year old looks in the mirror expecting to see a noticeable change on the morning of his birthday, but how many of us will make the same childish mistake on New Year’s

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

Day?

It’s ridiculous when adults expect to see change the very next morning after making a resolution. The first of the year does not instantly bring a whole new version of who y

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

Combination pro

u are. If you are going to make this your best year ever, you are going to have to do more than make a new year’s resolution and rip the plastic off of your new desk calendar.

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

he first week in January is the week when employees are all flying high, ready to change the world, get themselves organized, or land those big accounts. However, by the time Feb

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

uary rolls around, everything is back to usual. This is because they lack the strong foundation needed to carry out their resolution.

Sticking to a New Year’s resolution is more

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

than just changing your actions. Actions are a reflection of a deeper foundation. Without strong roots, positive actions wither as quickly as cut flowers in a vase. Eventually,

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

the temporary solution will wear off, and you’ll be in the same situation you were in last year.

Strong resolutions require positive attitudes that will feed and nourish your ac

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

ions for a long time to come. If you want to make real change, you must have the willingness and readiness to change, as well as the resolve to stick with it no matter how tough

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

Following aspects would a

t gets.

Before you make your New Year’s resolution, stand in front of the mirror and literally look yourself in the eye. Be completely honest with yourself. Are you truly ready

dd to the challenges in developing combination products:

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

for this change? Did you make the resolution because you felt you should, or is this something that you really want and feel you must do?

You’ll find that it’s hard to lie to y

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

urself if you’re looking at yourself in the eye. If you’re truly ready for a change, you’ll know it. Now is the time to plant the seeds of positive change by telling yourself ex

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

ctly what you need to do to make the change.

If you resolve to make more money this year, say to yourself aloud what you need in order to make more money. Be specific. Affirm y

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

our goal in a positive, actionable way, giving yourself an image to work with. Don’t focus on the desired result of your goal – that is something you do not have control over. F

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

Professional from academic institutions, pharmaceutical industries, health care indust

cusing only on the result will add pressure, and will have a negative impact on the attitudes that breed positive actions.

If more money requires you to find more customers, tell

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

yourself, “I’m going to meet 100 new prospects this year.” Your mind will instantly picture those 100 prospects and begin to work on the task at once.

As you make your positive

.

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

affirmations, look yourself in the eye. Seeing and hearing yourself declare your goal will give you the belief in your words to carry out the verbal contract you just made with y

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

Companies that provide selfless information through particip

urself.

Combining belief with positive affirmation will give you the foundation you need to succeed with your resolutions. The phenomenal results will be yours for years to come

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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The configurable auditing features available in some automated records management systems. The advantages of using an audit package in conjunction with a records management system are illustrated.

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