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The modern technology gives us the opportunity to “open” the existing concept of a book. Nowadays, i

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

n addition to reading a book in the old fashioned way, one can listen to audio book in one of at lea

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

Examples of combination products may in

st 3 methods: An audio book on a cassette, an audio book on a CD or an audio book in the format of

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

a MP3 or other audio file. In this article we will examine the different parameters that one should

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

consider when buying a new “book”:

1. Size and Weight – The smaller and lighter, the better. Carryi

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

Combination pro

ng a big and heavy book could by a hassle. In this parameter the most modern method is certainly the

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

best one – one can have several books on one MP3 player like an Ipod. The next audio book methods 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

ccording to this parameter in a descending order are audio books on a cd and audio books on cassette

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

s (one book can be converted into more than 20 cassettes).

2. Comfort – In this parameter the opini

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

ons are varied. Most claim that the new MP3 audio books are the most convenient ones. The disadvanta

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

ge is that one can continue listening to the audio book only from the exact point he stopped at the

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

Following aspects would a

last time. That’s why some still insist that there is no real substitute to the convenience of the o

dd to the challenges in developing combination products:

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

ld fashioned books.

3. Price – The price varies according to the different titles. In general, aud

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

io books on MP3 files are the cheapest. Audio books on CD and on cassettes are more expensive. None

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

of them clearly costs more. Comparing to the old fashioned book, we find that it usually costs the s

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

ame as the audio book on a MP3 file.

4. Variety – All the bestsellers could be found on the differe

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt methods of the audio books. However, most of the books are published only on the old fashioned wa

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

y – the printed one. Yet, In the past couple of years, the amount of new audio books is growing rapi

.

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

dly.

Each one should take into account the different parameters and make his decision. We assume th

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

Companies that provide selfless information through particip

at most of the people will find that the best audio book method for their need is the MP3 audio book

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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What is your philosophy of selling? Most people think selling is all about talking. I contend that selling is all about effective listening.

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