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A normal 625 line frame (we will use the PAL standard in this example)takes 1.2 Megabytes of data if no compr

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

ession is used. As there are 25 frames per second, this will give us: 1.2 x 25 = 30 Megabytes per second

So

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

Examples of combination products may in

a DVD with 4.7 Gigabyte of storage will give us: 4700 / 30 = 156.6 seconds or 2.6 minutes of video playback.

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

Obviously some way of reducing the amount of data that needs to be stored on the disk is needed.

One way to

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

compress the data stream is to analyse each frame and remove information that is repeated within the frame. T

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

Combination pro

his frame by frame compression is called JPEG. This might be ideal for individual frames but is not sufficien

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

for movies. Jpeg looks best with compressions of 5:1 or less, even this will only give 13 minutes of video

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 a DVD.

A better method is to use MPEG compression. This works by taking the first frame and compressing it

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

as above. This frame is still quite large as it contains most of the information about the frame, this is cal

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

led the I frame. The next frame of picture information is compared to this I frame and only the difference i

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

stored. There are two types of difference frames, B and P frames, B frames are bi-directional, and P frames

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

Following aspects would a

re predictive. The fact is that B and P frames can be quitr small depending on the amount of movement within

dd to the challenges in developing combination products:

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

the picture information. Typically with MPEG we can realise cpmpression factors of upto 30:1.

The grouping o

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

f I, B and P frames is called a GOP structure (group of pictures) the default stucture of a GOP within a DVD

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

s usually IBBPBBPBBPBBPBBI, 4 P frames within each I frame sequence, and 2 B frames between each P frame sequ

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

nce. A GOP sequence of 16 will give a very good compression ratio and take up less disc space but may presen

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

Professional from academic institutions, pharmaceutical industries, health care indust

problems as below.

In the DVD authoring process certain functions have to happen on an I frame and as each

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

GOP can only have one I frame then for some videos a smaller GOP structure is more flexible but take up more

.

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

pace. Foe example a chapter point has to happen on an I frame, if the GOP structure was 16 frames you might f

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

Companies that provide selfless information through particip

nd the nearest I frame upto 8 frames away which might result in an inaccurate position to begin a new chapter

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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