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Imagine a group of friends having a good time, talking about diffe

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

rent things. After a while, they start to talk about the Da Vinci

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

Examples of combination products may in

ode film. Some of them had read the book and had not watch the fil

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

m yet, others had read the book and also watched the film, so all

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

f them have a good knowledge of what is the story about, so they c

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

Combination pro

n participate in the discussion.

Imagine now that one of those fr

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

iends is blind.

Some years ago, he would have been out of the dis

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

ussion. He would not have been able to watch the film, and unless

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

omeone had read the book to him (hundreds of pages!), of course he

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

would not have been able to know about it.

But he is one of the

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

ost active participants in the discussion, talking about every det

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

Following aspects would a

il of Da Vinci Code. How? Because he owns a Da Vinci Code Audio

dd to the challenges in developing combination products:

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

book!

An audio book for the blind is an excellent solution, a

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

d not only best sellers as the mentioned audio book are found in a

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

dio book stores, but also thousands of different titles across hun

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

dreds of categories, such as history, humor, business, self help a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d many more.

And every day appear new ones, so in the near future

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

they will find almost any printed book as an audio book. For the b

.

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

lind these are excellent news, they will be able to listen to all

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

Companies that provide selfless information through particip

ind of books, and never be out of a discussion about a best seller

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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