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I love spoken-word audio. I've been listening to seminars, lectures, and books on tape for years.

I love downloadable audio. Missed that teles

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

eminar you signed up for? Just download the MP3 (or Real Media, or Windows Media, or QuickTime) file and it's almost as good as being there--ma

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

Examples of combination products may in

ybe better.

But I really dislike streaming audio of the kind you can't download, and I find the new trend to use Macromedia Flash to pr

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

ovide audio clips online particularly irritating.

Why? Because I don't want to have to sit in front of my computer screen to listen to somethi

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

ng. The only time I might want to do that would be if I were taking notes, or if the recording were a set of instructions on how to do somethin

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

Combination pro

g with a computer program. When I'm at my computer, I'm usually busy doing something that requires concentration (like writing).

I want to do

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

my listening when I'm away from my computer and doing something that occupies my hands but not my full attention. In my case, that's primarily

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

when I'm driving and when I'm cooking. And while I could theoretically prop my laptop on the passenger seat while I drive, I can't (yet, anyway

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

) get a connection to the Internet while going 65 miles an hour. Besides, the car stereo has much better speakers than the laptop does.

The wh

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

ole point of podcasting, after all, is to allow people to download and listen at their leisure, the same way RSS news aggregators let you colle

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

t blog headlines and other news at your own convenience. These streaming-only audio clips (.ram as well as Flash) don't give you that option. A

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

Following aspects would a

nd that snarks me off.

And yes, I do realize that people want to protect their intellectual property and that's one reason they use non-downlo

dd to the challenges in developing combination products:

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

adable streaming audio. I respect that. But I don't want to sell or otherwise redistribute their material. I just want to listen to it on my

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

time. To users of streaming audio I pose the question: would you rather I just didn't listen? Would you really prefer that I just miss you

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

r marketing message altogether?

Because that's what was happening before I thought of a way around the Flash barrier.

In May I made one of my

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

best investments of 2005 and bought a $10 mini-stereo audio cable. I plug one end into the laptop's headphone socket and one end into the cass

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

Professional from academic institutions, pharmaceutical industries, health care indust

ette recorder's microphone port. Or I plug the other end of the cable into the microphone port on the laptop and record it onto my computer to

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

play on my new MP3 player. (My current preferred recording software is the freeware program Audacity, available at http://audacity.sourceforge.

.

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

net/download/ in versions for Windows, Mac, and Linux.)

It works like a charm. I now have access to all kinds of things I never would have lis

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

Companies that provide selfless information through particip

tened to before, all thanks to a simple cable.

Now all I need is one of those car stereos with an MP3 player built in.

(c) 2005 Sallie Goetsc

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/57090/diggit-Why-I-Hate-Flash-Audio-and-What-I-Did-About-It.html">Why I Hate Flash Audio and What I Did About It</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/57090/diggit-Why-I-Hate-Flash-Audio-and-What-I-Did-About-It.html]Why I Hate Flash Audio and What I Did About It[/url]

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Digg It - Why I Hate Flash Audio and What I Did About It

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