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Some changes happen because of some incident or accident. Someone got fire

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

d because of an unforeseen reorganization. How do you handle such a change

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

Examples of combination products may in

? Do you pursue a revenge or will you search for a new way for your life?

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

"Revenge is not always a good idea," said the author of Slaughterhouse Fi

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

ve in an interview last year. And as change is concerned he is right. Reve

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

Combination pro

nge will take you nowhere.

Perhaps you could have prevented your dismissa

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

l. Perhaps you could have competed a bit more to save you job. But it is 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

so possible that it just happens to you –- "You could be the next one, or

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

do you think that this will not happen to you," replied the Queen to Tony

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

Blair at the end of the movie.

So just take for granted that anything wil

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

l happen to you on day. And than what will you do?

Revenge will take you

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

Following aspects would a

nowhere, but you will have to face the emotion. Putting your energy on emo

dd to the challenges in developing combination products:

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

tions that lead to a dead-end is one strategy. Revenge remains of all time

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

s. But is it an effective change strategy, or could you do without?

Only

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

ust now I searched for the little "poem" somewhere in the middle of Slaugh

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

terhouse Five. In vain. But it must be there somewhere on the web. I think

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

Professional from academic institutions, pharmaceutical industries, health care indust

that the idea was this:

I hope that I can be wise enough to influence

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

things that can be changed and strong enough to let go of that what I can

.

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

not influence anyhow...

If you really want to get somewhere you will

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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