Useful Advices - Business

HD stands for High Definition (HD) and is essentially a video format which is digital in nature and offers the promise of sharper, clearer pictures and sound than currently available using analogue video and te

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

levision formats.

There are two standards (commercially current) of HD which are 720 and 1080.

Each can be shown and recorded in two different ways, Interlaced and Progressive.

This gives rise to the four co

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

Examples of combination products may in

mmonly stated standards which your display device is capable of showing namely:-

720i, 720p, 1080i, 1080p where (i) stands for interlaced and (p) stands for progressive.

To understand which is better and whic

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

h standard you should seek out it is worth first looking at the common PAL system which is used currently in the majority of VHS, DVD and television broadcasts.

The amount of information contained in a picture

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

is directly related to the quality of the image able to be displayed. For PAL we have a picture which consists of 576 lines and 720 columns per line. This in computer “speak” gives us a number of possible pixel

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

Combination pro

s per image of 414,720. Pixel shape is rectangular.

If this raw information is displayed on a screen the clarity will decrease as the screen size increases – will look fuzzier. This is because the same number

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

of pixels will still be present but each will be larger for a larger screen size.

There are clever algorithms which will divide these pixels into smaller units so that the image on a large plasma screen will l

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

ok better, however the raw information remains the same.

For 720 HD the resolution (number of pixels) increases to 720 lines by 1280 columns giving us a total of 921,600 using square pixels

For 820 HD the res

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

olution (number of pixels) increases to 1080 lines by 1920 columns giving us a total of 2,073,600 using square pixels

Thus PAL has half the resolution of 720 HD and a fifth of 1080 HD.

The next problem is how

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

to get all of this information to the screen to show a smooth motion which looks natural and has no jerky movements and in sport for instance the football moves across the screen without leaving a ghostly trai

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

or shadow, known as video lag.

In the PAL system images are shown using a method known as interlace (i).

Interlace shows the video images as two fields which we call odd and even. The odd fields is lines 1,

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

Following aspects would a

3,5,7…575 and even fields are 2,4,6,8,…576.

The full image is made up of both fields but to show both “halves of the image” at the same time. As the display of moving video is actually a sequence of stills sho

dd to the challenges in developing combination products:

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

wn in sequence (25 per second) the engineers devised a method which showed for the 1 of 25 stills just the odd lines and for the 2 of 25 stills just the evens, whilst leaving the odd fields up from the first im

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

age. The next still shows the odds of the 3rd image and the evens from the previous still. This iss repeated and gives the appearance of motion, it is also why when you freeze frame the image is never as clear

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

s you’d expect.

This works because the human eye has a thing called latency, in which the image it sees remains in the retina and fades as a new image is seen. An extreme example of latency is to look at a bri

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

ght light and then look away – you still see the bright light although it is not present.

The use of interlaced transmission and processing tricks the brain into thinking it is seeing a full motion image when

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

Professional from academic institutions, pharmaceutical industries, health care indust

it is not.

The alternative method is to show the whole of each image completely, however this requires a lot of processing power and is now possible due to the technical advances made in electronics. This is c

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

lled Progressive display.

So the difference between PAL, 720i and 1080i is the amount of data with which the eye is presented.

720i and 1080i are a vast improvement on PAL and you will notice a significant im

.

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

provement in the clarity of the image and the amount of detail able to be seen.

The same level of improvement again would be displayed with 720p and 1080p which do not use interlaced video display methodology.

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

Companies that provide selfless information through particip

DO NOT however think that the selection of 1080p is automatically a superior image to that of 720i. The size of the screen, how far way the viewer is and how the original footage was obtained is very relevant

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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