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When you listen to a live musical instrument, the sound you hear is an analog sound wave. Such a wave can take an infinity number of values. This signal has to be converted into

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

a sequence of numbers (0s and 1s in native machine language) for storage and playback on a computer. This process of digitisation creates a raw digital music file which uses 10MB

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

Examples of combination products may in

or more per minute (at least 30MB for a 3 minute song).

On a PC, a .WAV is an example of a default audio file, while AIFF(Audio Interchange File Format) is the default format on

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

a Mac. On a Unix machine, Sun Microsystems' AU(AUdio) format is the default for audio. These file formats are an exact replica of the original sound, except for small sampling e

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

rors. (They also support limited audio file compression.)

These files have to be compressed to the more usual levels of 3-5MB per song. Compression rearranges the sequence of nu

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

Combination pro

bers, sometimes throwing away less significant information, in order to reduce the file size. The way the compression is achieved leads to the many different audio file formats a

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

vailable. Each compression algorithm requires a decoder to make sense of the data during playback. The combination of a compressor and a decoder is called, surprisingly, a codec.

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

COMPRESSION TYPES

There are two broad compression types:

1. Lossless codecs. This kind of compression reduces the file size while retaining every scrap of

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

information from the original file. This means that the original file can be reconstructed exactly as it was before the compression. Lossless compression does not significantly

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

educe the size of an audio file. Examples of general lossless compression algorithms include zip or gzip compressions.

2. Lossy codecs. These throw away some of th

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

information from the original music file. Ideally what's thrown away is what the human ear cannot hear, namely sounds below 20Hz and above 20KHz. Thus, the most successful lossy

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

Following aspects would a

codecs are based on an understanding of psychoacoustic perception. Lossy compression can reduce the size of the file to less than 10% of its original size. Most of the codecs yo

dd to the challenges in developing combination products:

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

will come across are of this type. Examples include MP3 and WMA codecs.

CONSTANT V VARIABLE BIT RATE Something else you might come across concerning compression is bit

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

rate. This is the number of bits (0s and 1s) per second in an audio stream. This kind of represents how much information is being conveyed per second. The bit rate within a singl

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

music file can be constant or variable.

A. Constant bit rate (CBR). The music/audio file is compressed to the same level throughout the file. For example moments

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

n the audio file having only a drum beating are reduced to the same bit rate as moments having all musical instruments playing at the same time. You would think there is more inf

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

Professional from academic institutions, pharmaceutical industries, health care indust

ormation to convey when all instruments are playing at the same time than when only the drum is beating. You would rightly choose a high bit rate to accommodate the complex sound

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

from all the instruments. But a higher bit rate results in a correspondingly larger file.

B. Variable bit rate(VBR). Each moment is compressed to a different bit

.

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

rate depending on the complexity of the sound. For example, while the drum beat alone can be compressed at 96 Kbps (kilobits per second), the moments with all musical instruments

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

Companies that provide selfless information through particip

playing could be compressed at 256Kbps. This results in a smaller file size without sacrificing the quality of the music. Remember file size is inversely proportional to bit rate

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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It's a fact: the best jobs attract loads of competition. So it pays to do whatever you can to stand out as a persistent, creative candidate, one that any sane employer would love to hire. But how can you do that, in this impersonal age of email, chat rooms and mega job sites? Easy. Just do what has worked for others.

Some people spend hours and hours designing great brochures and creating clever dialogue for the brochure. Then they spend a lot of money distributing the brochure through media with general circulation. Is this good marketing?

Most companies that are worthy of raising venture capital have proprietary Intellectual Property (IP). In fact, the quality of the IP and the management team are often the two most important aspects of a venture capitalist’s investment decision. The challenge that many ventures face, however, is that most investors will not sign non-disclosure agreements (NDAs), and NDAs are critical to maintaining the proprietary nature of the IP. This article details the appropriate strategy for addressing proprietary IP in your business plan in order to attract investor attention while retaining the confidentiality of your inventions.

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