Digg It - Business

Most people think they know what it means to be technically unemployed. The reason for the term "technically" is because no matter what one person may th

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

ink of as far as unemployment, your government may have a totally different idea and definition. Therefore, if you're currently not working and wonder if

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

Examples of combination products may in

you are considered unemployed then you might want to read this technical overview of just what it is that makes a person unemployed.

The reason to even g

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

o into this argument is because many people look at unemployment figures and think to themselves, "7% unemployment? That's not too bad." Well, maybe it'

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

not, based on previous numbers, but it's not a true reflection of how many people are out of work, because out of work doesn't mean unemployed.

Confused

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

Combination pro

You won't be.

To start with, let's say you're fresh out of high school, decide you don't want to go to college and instead want to go out in the world

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

and make a living. You start looking through the papers for a job. Are you unemployed? Well, you're out of work, but you're not unemployed. Huh? Well

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

it's like this. Since you never had a job in the first place you didn't have a job to lose, which is what unemployment figures show. So technically, yo

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

're not unemployed. This makes sense, otherwise every kid out of high school would be hitting the unemployment office.

Okay, so you finally find a job o

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

ut of high school but lose it after one day. Are you unemployed now? No, still not. You haven't been working long enough. For starters, you haven't ev

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

n made a pay check so you don't qualify for benefits, plus you don't have enough of an employment history to qualify for unemployment. So technically, yo

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

Following aspects would a

're still not unemployed. Out of work, yes. Unemployed, no.

Finally, you get a job and keep it for a whole year. You lose your job for whatever reason

dd to the challenges in developing combination products:

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

. You are now unemployed and can apply for unemployment benefits, which come out to a percentage of the money you made, up to a maximum amount. Yes, the

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

e is a cap. So even if you were a CEO making six figures a year, your unemployment benefits may be capped at as little as $500 a week. Unemployment is a

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

real killer for CEOs.

So now that you're unemployed you remain unemployed until you find another job. Right? Well, not quite. Unfortunately, unemploym

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

ent doesn't last forever even if your out of work status does. Unemployment benefits, depending on the jurisdiction, can be anywhere from six months to a

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

Professional from academic institutions, pharmaceutical industries, health care indust

year. After that, you can apply for extended benefits, but eventually there comes a time when even if you don't have a job you are not officially counted

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

in the unemployment statistics unless you are registered with an employment agency and actively looking for work. If you reach a point where you say 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

heck with it because you can't find work and drop out of the work force, you are considered a discouraged worker but not counted in the unemployment stati

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

Companies that provide selfless information through particip

tics.

So the next time you hear the latest unemployment statistics just remember that there are a lot of unhappy people who are not a part of that figure

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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If transport industry is a game of soccer, there are sure signs that the goal posts are shifting.

Why do we use experts? To predict the future. Consider a patient who is asking a physician about the future effects of a certain drug, or the investor who is asking a stock analyst about the future prices of a certain stock, or the manager who is asking a human resource manager about the future performance of a certain candidate, or the brand manager who is asking a market researcher about the future sales of a certain new product. Should we believe these experts? History tells us that accurate predictions of the future are rare. Many examples exist where the brightest and most qualified individuals failed to see the future. This series of articles presents examples from the arts (see part I), business (see part II), and science (see part III).

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