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"If you want to make your dreams come true, the first thing you have to do is wake up." -- Anonymous

We all have dreams, and I don't mean the kind we have at night. They can be anything from

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

swimming the Atlantic Ocean to winning the lottery to receiving the Nobel Prize to learning a new language. There are as many different dreams as there are people...times ten.

While dreams might be e

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

Examples of combination products may in

phemeral in themselves, there is one real fact about them, and it is embodied in the quote at the top of this article. While a dream MIGHT come true by accident or some happy combination of circumstan

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

ces, to MAKE a dream come true, we first have to wake up and DO SOMETHING. Simply sitting around waiting for a dream to come true is no more effective than hoping to win the lottery because someone gi

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

ves us a ticket. While that scenario could play out in real life, most lottery winners had to first actually buy a ticket.

However, just as buying a ticket, or a lot of tickets, in a lottery does not

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

Combination pro

guarantee our success; life does not provide us any guarantee that we will achieve our dreams just because we start doing the things that will probably be required to get us there. On the other hand,

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

just as our chances of winning the lottery improve with the number of tickets we are able to buy, our chances of achieving our dreams grows as we take more steps towards our goal.

Some steps that can

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

be taken include setting goals towards the accomplishment of our dream, learning and refining skills that might help us, enlisting the aid of those who might be in a position to help us, and, perhaps o

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

f the most importance, persevering in our quest.

GOALS: We humans are goal-oriented creatures. Just as we are more likely to arrive at a physical destination if we know where we are going, having go

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

als allows us to have a path to follow to the accomplishment of our dream. Once we have set goals to guide us, we will begin to notice events, information, and people that can aid us.

SKILLS: We can

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

ot become a champion runner until we learn to walk first. Once we learn to walk, running may come naturally, but running in a championship manner is something that has to be learned and practiced. Ad

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

Following aspects would a

ditionally, a champion in almost any field has to learn other skills or talents which complement the attainment of the dream. Turning to sports once more, our championship runner will have to pay atte

dd to the challenges in developing combination products:

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

ntion to nutrition, get the right amount of sleep and rest, and may need to learn exercises not specifically linked to the sport but which will improve performance.

OTHERS: Many times, we will be abl

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

e to find coaches or mentors who can help guide us on our path, just as a runner may need a coach who knows about the training required to compete at a professional level. Others may simply provide a

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

shoulder to cry on when we are down and certain that there is no way we can ever succeed. Some coaches or mentors can be found in books, by the way. If you are not sure how to get to where you want t

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

go, read the biographies of a couple of people who did make it.

PERSERVERANCE: There are many, including myself, who say that one of the most important factors in success is simply the good old abil

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

Professional from academic institutions, pharmaceutical industries, health care indust

ity to stick to it, no matter how rough the road or far away the target is. Almost every field of human endeavor is replete with stories of those of ordinary skill and intelligence who reached the ape

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

x of their field just by not giving up.

Since I began this article with a quote, I will leave you with three:

"Eighty percent of success is showing up."
-- Woody Allen:

"I have not failed. I've j

.

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

ust found 10,000 ways that won't work."
-- Thomas Edison:

"Ah, nothing is too late,
Till the tired heart shall cease to palpitate.
Cato learned Greek at eighty; Sophocles
Wrote his g

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

Companies that provide selfless information through particip

rand Oedipus, and Simonides
Bore off the prize of verse from his compeers,
When each had numbered more than fourscore years."
-- Henry Wadsworth Longfellow, from Morituri Salutamus

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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