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Diabetes is a troubling disorder and growing in frequency in the United States. Western medicine offers a variety of treatment options, but so does Eastern

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

medicine.

Diabetes is a disease that is rapidly getting out of control in the United States. The incidence rate is approaching 15 to 20 percent in certain

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

Examples of combination products may in

population groups such as the elderly. Non-insulin dependent diabetes is the most common form of the disease. It is characterized by low sugar levels in th

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

e body and its cause is often related to lifestyle issues. It is interesting to note that the earliest mention of a condition that appears to be non-insulin

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

dependent diabetes in ancient Chinese texts referred to it as a disease of the rich. It suggested that the rich would not be willing to give up the excesses

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

Combination pro

of their lifestyle.

The disease is far more prevalent in the United States and Europe than in the Orient, but it is on the increase there. This is thought

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

to be the result of the modernization that is bringing the same harmful diet and lifestyle choices as are available in the United States. This idea of the

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

effect of lifestyle on the onset and course of the disease suggests the first approach of Traditional Chinese Medicine to its treatment. First comes diet an

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

improved lifestyle. Any of the twenty or so herbs that have been used in the treatment of diabetes for centuries would come next.

Acupuncture is the third

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

step. It has been said that an acupuncturist is going to be better able to treat diabetes simply because he will tend to spend more time with the patient t

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

han most busy Western doctors. This is because the acupuncturist is interested in the lifestyle of the patients. He needs to know factors about his life and

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

Following aspects would a

condition that the doctor would not deem important. This is because the acupuncturist is going to see even the diabetes as a symptom of something amiss in

dd to the challenges in developing combination products:

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

he body, and not the problem itself.

For example, although many patients showing the onset of diabetic symptoms are also suffering from weight problems and

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

might even be obese, this could be misleading. Overweight people are thought to have an excess of yin and a deficiency of yang. Closer examination will oft

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

en reveal a deficiency of yin. This deficiency causes excessive heat that further stagnates the yin until the qi is impacted. The patient suffering from adv

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

anced diabetes will end up with deficiencies in qi, ying, and yang.

There are as many as twenty good energy points for the treatment of low blood sugar. Us

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

Professional from academic institutions, pharmaceutical industries, health care indust

ally, a dozen of these points are selected in each treatment depending on the patients overall situation. Many Western doctors have begun to give a cautious

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

recommendation to the consideration of Chinese medicine. They have not been able to argue with the results. Although they do not accept the premises of why

.

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

these treatments are successful, they will still suggest that it might be attempted as long as the more conventional treatment methods are retained. There

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

Companies that provide selfless information through particip

is actually much common ground. Both disciplines recognize the impact of diet and lifestyle and their recommendations for maintenance are generally the same

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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