Advice Pool - Health and Fitness

Diabetes is becoming more and more of a problem in Western society. The Chinese have long dealt with the issue, but from a very different pe

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

rspective.

Diabetes is a metabolic disorder that is generally characterized by high blood sugar levels. It is usually divided into two majo

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

Examples of combination products may in

r classes. Type I diabetes means that the patient is almost entirely insulin dependent. There body does not produce insulin at all or in suf

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

ficient quantities. Type II patients are not insulin dependent, and their bodies still produce significant amounts of insulin. The body does

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

not process this insulin properly, however, and the symptoms and indications of both types of the disease are similar.

Traditional Chinese

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

Combination pro

Medicine calls diabetes “depletion-thirst disease.” It actually divides the disease into three different types. They are upper, middle, and

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

lower depletion-thirst diseases. As is usually the case in Chinese Medicine, the causes of the disease are seen as being more often lifestyl

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

e related although there is some congenital causation. Such factors as overeating of greasy food, over consumption of alcohol, and even an i

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

temperate sex life are seen as leading to damage to the kidneys and other organs. Such things as anxiety, anger, and mental depression also

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

lead to organ damage and result in the body’s failure to produce or process insulin.

There are many different herbal remedies available in

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

Traditional Chinese Medicine. Many of them have been used for centuries, but recently some scientific research has been done on them with su

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

Following aspects would a

rprising and encouraging results. Berberine which is an extract found in the roots and bark of several plants had been used for the treatmen

dd to the challenges in developing combination products:

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

of wound healing and diarrhea. A joint study done by Chinese, Korean, and Australian doctors has found that berberine has been shown to red

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

uce glucose levels and is promising in the treatment of type II diabetes.

Yu Xiao San 8805 is another herbal product. Experimental tests do

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

ne in the United States and China have shown very good results in restoring pancreatic function and increasing the production of insulin bet

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

a cells. No adverse or allergic reactions were seen and no damage to liver, kidney, or other organs was observed. This is an example of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ery encouraging therapeutic uses of Traditional Chinese Medicine’s herbal cures for diabetes.

The Chinese methods of treatment of “depletio

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

n-thirst disease” differs from Western Medicine in that, as usual, it considers the overall situation of the patient rather than focusing on

.

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

just the acute symptoms of the illness. Much of the treatment systems are designed to relieve the causes that led to the condition. The fac

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

Companies that provide selfless information through particip

t that some of the classical herbal remedies are being studied in the West is an encouraging sign to millions of diabetes patients worldwide

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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