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It is often called a silent condition, one that might occur without the afflicted person knowing. For thousands o

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

f travelers and inactive people annually, it is a problem that can cause lasting damage if steps are not taken to

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

Examples of combination products may in

prevent it from happening. Deep vein thrombosis poses a serious risk to men and women of all ages.

What is D

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

eep Vein Thrombosis?

Deep Venous Thrombosis (DVT) is a condition defined by a blood clot, or thrombus, formi

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

ng in a deep vein. Commonly affecting the leg veins, such as the femoral, popliteal, or the deep veins of the pel

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

Combination pro

ic region, DVT can prove fatal if the clot comes loose, makes its way into the blood, and enters the heart.

W

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

hat causes Deep Vein Thrombosis?

While recent research shows that various factors prove to put a person at r

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

isk for DVT, a more common cause for deep vein thrombosis is inactivity. The less you move, the slower your blood

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

circulates, thereby increasing the chances for clots to form. Business travelers, people who spend long hours in

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

cramped airplane seats or in cars, and people confined to wheelchairs are especially at risk if they are unable

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

o regularly circulate the blood in their legs.

What measures can be taken to reduce the risk of DVT?

Tha

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

Following aspects would a

nkfully, DVT is such a condition that can be prevented if one knows what to do. For many, alleviating oneself of

dd to the challenges in developing combination products:

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

risk can be as simple as staying active. Maintaining good circulation throughout the body is the key to preventin

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

g blood clots. When the blood pumps constantly through the body, the opportunities for clots to form decrease.

O

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

ffice workers may wish to take occasional breaks to walk around and get the blood flowing. Leisure activities lik

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

watching TV, where the body is inactive, can be done with the legs elevated, so blood flow has a chance. Air tra

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

Professional from academic institutions, pharmaceutical industries, health care indust

velers should try to move their legs as often as is allowed. A trip up and down the aisle of a plane can do wonde

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

rs for tired, cramped legs. Investing in a good ergonomic device, like a massaging cushion for work or travel, ca

.

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 help stimulate blood flow when motion is not possible.

An internet search will lead you to more detailed infor

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

Companies that provide selfless information through particip

mation about DVT, its causes and remedies. Do your research and listen to your body. Keep active and stay healthy

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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