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My name is Alan Twigg and I'm writing this article to offer advice to anyone thinking of creating their own professional audio boo

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

ks.

In the New Year I came up with the idea of creating professional children’s stories and offering them for download on the int

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

Examples of combination products may in

ernet. The thing was, however, while I had someone to write the stories - my mother - and someone to market the stories – me, I kn

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

ew nobody who knew about how to record the stories professionally. I knew it must be reasonably easy, since I only wanted to creat

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 an audio book containing speech.

I started doing research on Google - but all the articles I found contained so much technical

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

Combination pro

gobbledygook – I was soon put off. So I went to my local music store for advice on what to buy. I decided to use my computer to cr

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

eate the audio books and this is what I bought:

1 microphone stand

1 pop-screen (that's a piece of material that is placed just

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

in front of the microphone to stop your “Ps” from popping)

1 studio microphone

1 software program (Wavelab)

1 USB Audio/MIDI in

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

terface (TASCAM US 122 with phantom power)

1 pair of heaphones

It all came to 650 euros (800) dollars.

I connected my Audio/MID

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

I interface (this is basically a really good sound card in an external case) to my computer using the USB cable provided. I then s

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

et up my microphone and attached the microphone cable to the MIDI interface. After installing the software, I was ready to go.

Th

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

Following aspects would a

e results have been great and I find Wavelab software powerful and incredibly easy to use.

Some Audio Book recording tips

I firs

dd to the challenges in developing combination products:

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

t get my entire copy ready before starting the recording. I pin the sheets of paper with the text that I am going to read in front

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

of me onto the wall. Then, at about 8 inches away from the microphone, I start to talk. The more natural you can be the more inte

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

resting you will sound to your listeners. I found that the best thing to do is to stand in front of the microphone and make gestur

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

es in the same way as you would when talking to a close friend. If you stand there stiff like a statue, you'll come across in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

same way in your recording.

Another thing that I like to do before starting the recording is to get myself into a really good moo

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

d. Again, this will add to the impact of your recording. I always listen to a few uplifting songs and get enthusiastic before star

.

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

ting. You should also try to make sure that you keep the same distance from the microphone.

And that’s it – I hope that this arti

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

Companies that provide selfless information through particip

cle will save you a little bit of time setting up your own home recording studio and I wish lots of success with your audio books.

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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