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We often communicate with people that heard others talking about audio books, but do not know really what they are. There are two different versions of audiobooks, b

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

ut what is the difference? People are always interested in multitasking while they can save time, because we have such limited free time. Audiobooks are perfect for

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

Examples of combination products may in

multitasking , let's take a look at what an audiobook is and the main differences.

What is an Audio Book?

An audiobook is taking a regular traditi

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

nal book (you must have the copyright permission) and vocally reading the book while recording the narration. A book is recorded with either one narrator that covers

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

all the characters within the book or a cast of narrators that do the voices for one or two characters each. The recording contains the voices of the narrators but

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

Combination pro

ackground music and sound effects can also be added to the audio book for additional dramatic effect. Both styles are great, but it is the story and type of writing

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

hat determines if background music and sound effects are added.

Basically audiobooks come in two different versions:

1. Unabridged Audio Books - 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

n traditional book that is narrated word for word from front cover to the last back page. The audio book is narrated exactly the way the author has written their boo

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

, if it is an older book the text may be updated to current times. The entire story is read with nothing removed from the story line, this is the most important aspe

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

t of unabridged audiobooks.

2. Abridged Audio Books - you guessed it, the opposite of unabridged audiobooks. A book is professionally edited down in size to just

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

he essence of the story line. Each section or chapter of a book is carefully read and the crucial parts of the book are kept in tact. It does not mean the areas th

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

Following aspects would a

at are cut out are not important, but in fact the areas that are kept are essential and crucial to the story.

As audiobooks grow in popularity, many more titles wil

dd to the challenges in developing combination products:

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

be published into audio books. There are thousands of audiobook titles available, but each year this number grows at a vigorous pace. Audiobooks allow you to enjo

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

your books while doing other tasks everyday. Most people will listen to audiobooks while they are commuting, travelling, cooking, exercising and a lot of other act

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

ivities. Basically, you can listen to audio books no matter what you are doing.

How is an Audio Book Made?

Once a book title is selected that wil

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

be converted into an audiobook, it is time to select the support staff such as narrators (story tellers), publisher, editor etc... When all the support staff is se

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

Professional from academic institutions, pharmaceutical industries, health care indust

ected then the next step is to have the narrators read the book while it is being recorded. When the narration is complete and accepted, then the sound people go to

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

work in editing and cutting the audiobook into a finished product. The audiobook is then brought into the marketplace for listeners to appreciate.

This is a very

.

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

imple look at the audiobook creation process to give you a brief example. The process is not as simple as this, there is a lot of work that goes into making an aud

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

Companies that provide selfless information through particip

obook. More than just meets the eye, there are a lot of people involved in creating an audiobook so people can site back and relax listening to their favorite 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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