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Are you going to your works Christmas Party this year? Are you worried that you might do something whi

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

ch you may later regret when under the influence of alcohol? I am attending my own companies Christmas

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

Examples of combination products may in

party next week and after having been to a number of these events in the past, I have a number of ide

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

as of what to do and what not to do, ideas of which I will be writing about in this article.

I have w

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

tnessed some crazy things at previous Christmas parties that I have attended, from people getting drun

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

Combination pro

k and hitting the boss, to other people attempting to chat up the boss. These may seem quite funny whe

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

n looking back but at the time they were far from this. The weeks and months after these parties were

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

ess than comfortable for the people involved. The excuse of being drunk was not enough and the careers

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

of the people at the companies involved were basically over from that point.

The Christmas party is

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

a no win situation for the employees. If you keep too quiet you can be seen as boring and as not being

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

a team player. If you drink too much you can be seen as an alcoholic and like some sort of rogue.

I h

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

Following aspects would a

ave learned that to have a few drinks is fine but that it is important to take it easy on the alcohol,

dd to the challenges in developing combination products:

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

so as to not become too drunk. I would aim to drink about half the amount that I would on a normal ni

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

ght out.

The later the night gets the more likely it becomes of people doing something silly. My next

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

idea is to leave the party as early as possible but without telling anybody. When people ask where and

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

why you went, I would say that there was a crisis at home. People probably will not even remember tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t you left early as they are more likely to be talking about the people who did make fools out of them

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

elves.

My next tip is to think twice before saying anything to your boss. Before speaking ask yoursel

.

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

f a question, will what I am about to say get me into any kind of strife?

If you follow these snippet

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

Companies that provide selfless information through particip

s of advice I am sure you will enjoy your Christmas party and will not have any reason to have regrets

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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