Advice Pool - Self Improvement

I am sure you have seen “The Family Man”, it's one of these must-see-at-all-cost movies. If you haven't, I guarantee you'll enjoy it.

It is all about a single and very s

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

uccessful Manhattan businessman who thinks he has everything, with a lifestyle that the world envies - until his girlfriend Kate (Tea Leoni) of 13 years ago contacts him

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

Examples of combination products may in

nd he is confronted with his choice not to marry her at the time.

By some twist of events, Jack Campbell (Nicolas Cage) wakes up one morning to lead an alternate life of

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

being Kate's husband for a few weeks, happily married with two kids, selling tyres in the suburbs.

Why would that happen, you might ask? Because over his obsession with

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

business, he has completely neglected his personal life - and that's catching up with him now. You can't be out of balance for long, nature will always restore it - a Uni

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

Combination pro

versal Law that cannot be broken.

As human beings, sooner or later we have to experience life from all angles consciously open to us - but we have our priorities, and th

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

refore choices to make. For me this film is very relevant and believable.

What would have happened, for example, if I had not decided in 1984 to live and work in South A

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

frica?

At the time, my biggest dream was to no longer live in Germany where I was born and raised - the two years in London I had done previously weren't enough to satis

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

y my curiosity about people who live, learn and grow in cultures different from my own.

As difficult as our decisions seem to be at times, we should be grateful every da

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

y that we have the freedom to choose and that we do have the right - and obligation - to become what we can be and want to be. This, by definition, always includ

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

s our choice against everything we do NOT want to be.

Fortunately, the constitution of our country 'guarantees' that we may pursue any dream we have, as long as we take

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

Following aspects would a

the responsibility for our actions - not everyone can enjoy this freedom and comfort.

Be that as it may, if you want 'guarantees' buy a toaster. In my opinion it is more

dd to the challenges in developing combination products:

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

important to be aware that whatever we do to others will eventually be done to us, one way or another. That's something that I will personally guarantee, for what it's wo

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

rth.

If we all recognised that truth, I believe there would be a lot less suffering in the world, and more prosperity. But we decide to the best of our knowledge, so I m

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

st assume that right now most of us just don't know better.

One dilemma we often face in our choices is that we have to temporarily sacrifice something when we opt for o

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

ne route over the other. We can never really take a wrong turn though : at the end of the day, one way is as good as the other - may be it's a bit longer or more difficul

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

Professional from academic institutions, pharmaceutical industries, health care indust

than the alternative, but it is always exactly what we need to experience at the time.

Obviously, we sometimes need to give up familiar and comfortable positions to obt

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

ain a more comprehensive picture of our place in the universe - and in “Family Man”, Jack Campbell at first has a rude awakening to a life without his Ferrari and penthou

.

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

e.

But once he discovers that the treasure of a happy life with family and friends is worth so much more than any material comfort, he doesn't want to go back to his pre

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

Companies that provide selfless information through particip

vious existence.

Can we reverse our decisions? No, but with our new perspective we can adjust our course for the future. Be aware of your choices before you hit dead-end

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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Advice Pool - You Have A Choice, But No Guarantee

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