Advice Pool - Health and Fitness

About 17 million American’s have diabetes and approximately one third of them

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

don’t even know it. Diabetes is a disease that is a result of your body’s ina

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

Examples of combination products may in

bility to utilize glucose efficiently or possibly not able to utilize it at al

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

l. The results of leaving your diabetes untreated can be devastating. Blindn

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

ss, heart attacks, strokes, amputations are all possible consequences of diabe

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

Combination pro

tes and especially leaving it untreated. One of the most popular medications

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 the treatment of patients with diabetes is Glucophage (Metformin). This m

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

edication also now comes in combination with other products such as sulfonylur

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

as (Glucovance, Metaglip) and the glitazones (Avandamet, Actos plus Met).

Met

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

formin has been used for many years around the world and is a very effective m

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

edication for diabetes. Some of the more common side effects include nausea,

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

Following aspects would a

vomiting, bloating, diarrhea, and loss of appetite. These symptoms generally

dd to the challenges in developing combination products:

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

ccur in one out of three patients. But one of the lesser known and yet very i

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

mportant side effects of Metformin is how it depletes some of your essential n

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

utrients and increases your odds of having side effects due to nutrient deplet

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

ion. The nutrients of most concern are Vitamin B-12, folic acid, and Coenzyme

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

Professional from academic institutions, pharmaceutical industries, health care indust

Q-10.

If you happen to be taking one of the products that has Metformin as we

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

ll as a sulfonylurea included (Glucovance, Metaglip), you should increase your

.

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

risk of reducing your coenzyme Q-10 levels even further, because the sulfonyl

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

Companies that provide selfless information through particip

urea class of drugs is known to interfere with the metabolism of Coenzyme Q-10

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 never ceases to amaze me that I see so many businesses leave their marketing efforts until they urgently need them - or often until well after. And at that stage it is often too late!!

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Advice Pool - Your Diabetes Medication May Be Depleting Important Nutrients

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