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Don't look now! Someone's staring at you from that far wall behind the artificial potted plants in this busy hotel lobby. But there's no need for that furtive glance like you h

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

ave some lint on your shoulder. There's no need for those tiny furtive steps either. No one's stalking you. It's just the hotel's CCTV surveillance system. The hotel has recent

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

Examples of combination products may in

y been caught up in the wave of video surveillance. That someone staring at you from across the room is just the camera from the newly installed CCTV surveillance systems. In h

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

tels and in places where there is high human traffic, state of the art CCTV surveillance systems have been mounted for purposes of safety and as crime deterrents.

That Cons

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

ant Fear
The world, it seems, is gripped by fear of terrorist attacks. In fact, after 9/11, it seems to be a Herculean effort to make life go on - do business, travel

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

Combination pro

interact with others in densely populated places. After all, if there's anything 9/11 has shown us, it is that a bomb could go off in a sidewalk while you are having an al fre

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

sco lunch with a colleague, or blow up the trans-continental plane you are in while it's in in the air, cruising at 125,000 feet.

The security guys you see milling about do no

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

reassurance you. You have always felt that security guys patrolling public places have a very limited capacity for preventing crime. They only act when something happens in th

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

ir line of sight. By then, however, you'd be beyond help.

You're Safe Now
Installed in a strategic spot and equipped with cutting edge technology in surveillance

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

ameras, CCTV surveillance systems can record everything that goes on in its line of focus. These recordings can later be retrieved and analyzed to recreate scenes.

Software de

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

elopers now see the potential of CCTV surveillance systems in preventing a repeat of large-scale terrorism after the 9/11 attack at the World Trade Center. These developers are

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

Following aspects would a

working hard to develop programs for surveillance systems, among them an important feature known as face recognition.

With face recognition installed in CCTV surveillance sys

dd to the challenges in developing combination products:

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

ems, it is now easy to recognize certain key features in the face of an individual. This face will be compared to a host of faces from a database of mug shots and photographs.

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

person flagged as dangerous can then be prevented from gaining access to buildings or public transportations, thus thwarting any planned attack or escape.

Big Investment T

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

at Pays Off
CCTV surveillance systems today now boast of functionalities not seen in the video surveillance systems of the past. This time, CCTV surveillance systems

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

ave

1. motion detection. This means that the surveillance system only records footage when movement triggers the surveillance system.
2. resolution as clear as day. Grai

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

Professional from academic institutions, pharmaceutical industries, health care indust

ny footage is not a problem anymore with some video surveillance cameras featuring 1600 x 1200 dpi, or even more, resolution.
3. night and infrared vision. Even with low

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

r minimal lighting, these new surveillance systems can record images with infrared technology.

Government administrators are seeing the positive side of surveillance systems.

.

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

n fact, after 9/11, federal budget is flowing in for these new security measures. There are states which require the installation of surveillance systems in business establishm

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

Companies that provide selfless information through particip

nts before these businesses can operate.

So, there is really no need to be afraid. CCTV surveillance systems, those new security guys, have your back. They are always watching

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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