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I will confess that for me personally my biggest arch enemy is procrastination.

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

I’m a sucker for it, for me getting ideas or initial enthusiasm is the e

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

Examples of combination products may in

sy part, it’s keeping up the momentum and following my idea through to co

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

pletion that’s the hard part. My mind will find an infinite number of thi

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

gs that I can do before I go ahead and follow my plan through. Even writing and

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

Combination pro

submitting this very article becomes a mammoth test of will power and focus. To

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

combat this dreaded enemy I have taken a different approach instead of just try

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

ng to force myself to commit to the task I have set for myself, I create smalle

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

easier tasks leading up to my main goal. I break it down and if I still fall i

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

to procrastination I break it down into even smaller more manageable tasks to t

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

e point when it’s almost as effortless as getting dressed in the morning.

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

Following aspects would a

I have found personally that by breaking each main goal down in this way it all

dd to the challenges in developing combination products:

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

ws me to get started on doing something! Before my mind has time to get bored o

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

overwhelmed by the task at hand.

Also by doing very small tasks everyday you

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

ill quickly find out that all your efforts will add up and amount to an enormou

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

workload that would appear very daunting if undertaken all at once. It's so mu

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

Professional from academic institutions, pharmaceutical industries, health care indust

h easier to do something little each day than to do something huge in a few day

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

! Do this right now, get a pen and a piece of paper and write your biggest goal

.

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

for this year, then right down your biggest goal for the month, finally write j

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

Companies that provide selfless information through particip

st 3 things you will do each day from now on till you achieve your monthly goal

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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