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Although MP3 is the most popular format for encoding music, it is by no means the only one. Th

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

ere are two basic methods for compressing audio – lossless and lossy, and for each of these me

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

Examples of combination products may in

hods there are many formats.

Lossless compression means that none of the audio data is remove

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

during compression. Lossy compression means that audio data is permanently removed from the a

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

udio file. Lossy compression results in smaller files, but there is no way to rebuild the audi

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

Combination pro

data to its original format. MP3 is an example of lossy compression.

Lossy Compression Forma

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

s

There are many alternatives to MP3 when it comes to encoding audio files. Microsoft reporte

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

dly developed the WMA format to avoid the licensing costs associated with MP3. WMA files can b

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

played with the Windows Media Player that is included with the Windows operating system as we

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

l as many other audio players. It features similar encoding rates to MP3 and similar file size

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

.

AAC (Advanced Audio Coding) is the format preferred by Apple and is used for its popular iT

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

Following aspects would a

unes and iPod products. AAC files can be smaller than MP3 files because it uses more efficient

dd to the challenges in developing combination products:

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

encoding technology. A 96 kpbs AAC file is similar in sound quality to a 128 kbps MP3 file.

O

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

g Vorbis is another type of lossy compression and uses .OGG as the file extension. It is an op

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

en-source product and unlike MP3, there are no patent restrictions on its use.

Lossless Compr

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

ssion

For the audio purist who insists on the best quality sound possible, lossless compressi

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

Professional from academic institutions, pharmaceutical industries, health care indust

n offers CD quality sound. The tradeoff is larger files sizes – while MP3 can compress audio i

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

n the range of 80% - 90%, lossless compression typically compresses the file by half.

Popular

.

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

lossless formats include FLAC, Monkey’s Audio, and SHN (Shorten). These formats are supported

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

Companies that provide selfless information through particip

y many audio players and are popular for archiving CD collections as well as for trading music

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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