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Your first job is setting the context for all next ones.

So you should

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

be carefull and that is why we go to school for. It is like playing foot

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

Examples of combination products may in

all and the ball is out. And it is your turn to get the ball back in. So

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

you are not waiting until you have arrived there at the line, watching 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

ere your team mates are and thinking, "where is the best place I will th

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

Combination pro

ow this ball." No, once knowing that it is your turn, you are already ob

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

erving the positions of the players and when you have arrived at the sid

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

e you throw the ball right where it should go.

There is a big differenc

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

between school and study and the real world outside. Some have the entr

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

preneurial spirit when they are still young and they present themselves

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

t the market.

Others start by a first job, and a second, a third... But

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

Following aspects would a

wait a minute, before you know it you are in the middle of a course you

dd to the challenges in developing combination products:

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

cannot longer escape from. You build up expertise and people hire you to

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

do the trick again.

So your first job sets the tone and direction for a

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

ll others. Do you accept the first offer presenting itself or do you tak

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

more time to find one that fits you better?

Finding a job that suits y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u is like outlining a business strategy. You have to take into account t

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

e market, your (internal) competences, trends, etc. But most of all, the

.

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

first step in implementing this strategy is dominating the rest.

Take y

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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Digg It - Your First Job Sets the Tone for the Rest to Come

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