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My friends and colleagues consider me as the audio books expert. They tell their friends that they know an audio books expert a

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

nd the outcome is that I keep getting dozens of audio books questions and inquiries each day. I have decided to gather the most

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

Examples of combination products may in

frequently asked questions for everyone’s benefit.

Here are the top five frequently asked questions about audio books (and the

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

answers of course):

1. Are there free audio books? How do I get them?

In one word: NO. In two words: Not exactly. Depends of

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

the type of audio book you are looking for (downloadable audio book are cheaper than the other types), and the audio book title

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

Combination pro

(new audio books cost more), you could find low cost audio books.

I believe that one should pay for each product or service he

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

gets. Yet, you could find free audio books mostly by signing up for the free trials most of the online audio book services giv

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

you.

2. What is better – Audio books rental or audio books buying?

I personally prefer audio books rental. Mostly because of

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

the price – I read a lot of audio books and it will simply cost too much to buy them all. However, audio books that I really l

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

ke, Ones that I want to listen to time after time, I buy and keep them on my audio books library.

Yet, I have friends who are

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

ore possessive – they are not willing to rent audio books and they must hold a remarkable huge audio book library.

3. What do

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

Following aspects would a

you suggest – downloadable audio books, audio books on CD or books on tape?

Well, that’s a tough question. Basically, I believ

dd to the challenges in developing combination products:

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

that the most worthy audio books format nowadays is downloadable audio books. You must own a media player (e.g. Ipod) to liste

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

n to it. Yet, it costs less than the others and has a better quality.

However, the widest collection of audio books could be f

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

und on the audio books on CD format. If you want to listen to old books you will find them only on CDs. I do not recommend get

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

ing books on tape (also known as audio books on cassettes). They are expensive, low quality and not user friendly.

4. When can

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

Professional from academic institutions, pharmaceutical industries, health care indust

I read audio books?

The answer is - Anytime and anywhere. Here are a few examples: While cooking, cleaning the house, exercis

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

ng, running, walking, driving, flying, before going to sleep, commuting, working etc.

5. Are audio books expensive?

Audio boo

.

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

ks are not expensive at all. In fact, Downloadable audio books are very cheap – they cost much less than real books and renting

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

Companies that provide selfless information through particip

them is the most worthy deal. Audio books on CD cost about the same as real books and books on tape are the most expensive ones

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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