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Managing change in our lives and in our businesses is vital in the modern environments in which we live. There is much to learn from that old and cantankerous Dick

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

ens character, Mr Ebenezer Scrooge himself...

The truth is, although he had an outward persona of grumpiness, deep down somewhere there was a man with a heart<

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

Examples of combination products may in

/b>, seeing his life drift away from him.

We all do this to some extent - to hide away our true selves behind a veil of something we are more comfortable with. 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.

metimes we appear intimidating, cruel or even harsh. We avoid the intimacy we really seek, because of past experiences.

For old Scrooge, this became clear with th

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

e visit of the three ghosts, as well as what I find the most scary of all, the visit of Jacob Marley, his former partner, who seemed doomed to be stuck in that no-

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

Combination pro

mans-land world between life and the ultimate infinity.

So, what happened then?

Firstly, Scrooge was reminded of who he might become if he carried on as h

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

e was. Marley gave him the example of the outcome of carrying on with his current behaviours.

Secondly, the Ghost of Christmas Past happened by. Showing Sc

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

ooge his almost forgotten past, where often he had experienced the fun that truly is possible, yet for so many of us is lost and overwritten by the experiences we

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

have, as we grow through childhood and adult life.

Thirdly comes along the Ghost of Christmas Present, where Scrooge becomes aware of opportunities every d

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

ay, perhaps even every hour, that we all have, yet our frame of mind causes us to miss them. Awareness of these possibilities is quite a step, yet when we start to take t

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

he time to notice, we can easily change our behaviours for the better, not just for ourselves, but by others too.

Finally, the ambiguous Ghost of Christ

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

Following aspects would a

mas Future. Will it happen, or is there a choice? Where Scrooge will end up if he doesn't make some changes. Interestingly, whilst Scrooge laughs along with th

dd to the challenges in developing combination products:

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

e Ghost of Christmas Past and gets into those wonderful experiences of his youth, he's not smiling anymore when it comes to the future. And, even more oddly, it se

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

ems that the impact on others, what might happen to Tiny Tim, hurts and frightens him the most.

What can we learn from this? Quite a lot actually...

Our past ho

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

ds the clues to who we might be.

We get stuck into one way of thinking and that does us no favours.

Focusing on money (remember he's a miser!), is an escape man

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

y of us choose.

There are possibilities every single day to get more from our lives - to be authentic with ourselves.

The future is impacted on by our behaviour

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

Professional from academic institutions, pharmaceutical industries, health care indust

s and actions - we can make a difference.

There is much pleasure for ourselves in helping others - it is not an action that causes us pain!

We have choices to m

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

ake and they are entirely in our hands. These are decisions we are making every day of our lives.

Managing change becomes all the easier when we realise what we had

.

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

, where we are now and what might become of us in the future, unless we choose differently. It really is up to us - and that is the challenging part.

Above

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

Companies that provide selfless information through particip

all, this enchanting story is well worth the read at this time of year - there are many more interesting lessons to learn.

As well as a delightful Christmassy story too

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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Just Other Articles - Scrooged - A Dickens of a Way to Manage Change!

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