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Most economies are equipped with two economic infrastructures; two different markets for

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

the same goods. You will not only find this in less developed economies with a parallel c

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

Examples of combination products may in

urrency market (next to the official currency market). But even in developed countries th

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

ere is the black market as opposed to the legal white market. Less dramatic differences a

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 there between the official stock market and the over the counter (OTC) market.

The boo

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

Combination pro

k market is still a very big market, which covers different sub types, for instance the s

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

econd hand market. The book market is a place where publishers sell books and where reade

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

rs buy them. Market number one. Another type is, a familiar kind of market but on a diffe

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

ent level; the self-publishing market. In that case the author is also publisher. The oth

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

er characteristics are more or less the same.

Recently I understand that in either marke

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

t you can make a fortune of books that are sold. If you are a talented merchandiser you c

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

Following aspects would a

ould easily sell large numbers of your own work. Switching from one market to the other

dd to the challenges in developing combination products:

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

s not that easy though. Again, this is not about something illegal like money laundering,

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

but a simple step from self publishing to the established book market. In many countrie

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

s there is no choice to operate in one or the other market, but in the book market there

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

is this choice, even if it is not an easy one.

If you choose to enter the unofficial mar

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

Professional from academic institutions, pharmaceutical industries, health care indust

etplace, it will be hard to switch later on. This means that you should consider this in

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

advance. Consider the tradeoff between the increased amount of energy you need on the sho

.

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

rt term to enter the official market, and the continuous extra energy you need in the uno

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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