Advice Pool - Health and Fitness

Type 2 diabetes is an increasing health problem worldwide. Most of the 194 million people with diabetes have Type 2 diabetes,

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

which is caused by inability to regular the sugar in the body properly. Diabetics are of high risk of developing other disea

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

Examples of combination products may in

es including heart disease, if their conditions are not well-managed.

A recent study revealed that an herbal therapy that ha

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

been used for thousands of years may help control blood sugar levels in people suffering from Type-2 diabetes. Milk thistle,

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

a flowering herb, contains several chemicals with possible medical effects. Most current research focuses on one of them, sil

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

Combination pro

ymarin, which may have specific protective effects on cells in the liver. Milk thistle can also produce modest reductions in

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

holesterol levels and help to protect the heart muscle from damage caused by certain drugs. However, these potential uses hav

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

not been well-studied in humans.

As reported in the Journal Phytotherapy Research, a study conducted by researchers from th

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

Institute of Medicinal Plants in Teheran seemed to indicate beneficial effects of silymarin for Type 2 diabetics.

The resea

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

rchers compared the effects of daily supplements of silymarin against a placebo in 52 diabetics. Half of the patients receive

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

200 mg of silymarin 3 times a day for 4 months or the dummy pill along with conventional treatments. At the end of the study

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

Following aspects would a

people in the herbal group had reduced blood glucose levels compared to their earlier levels.

The results were indeed very

dd to the challenges in developing combination products:

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

ncouraging but further large multi-center studies were necessary. Although some substances appear to have an effect in people

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

with Type 2 diabetes, it is warned that they should not be used as a cure and should not replace traditional therapies. As t

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

e study was very small and still in its early stages, it is not recommended to use milk thistle or any other supplement for p

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

ople with diabetes.

Women who have cancers of the breast, ovaries, or uterus or who have other hormone-dependent conditions

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

Professional from academic institutions, pharmaceutical industries, health care indust

hould not take or use milk thistle plant extract due to its possible estrogenic effects. Pregnant women should also not take

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

milk thistle because of it could interfere with normal fetal development. Men who have prostate cancer should not take milk t

.

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

istle without the approval of a doctor.

Despite the findings, researchers still stressed that the best methods of controllin

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

Companies that provide selfless information through particip

glucose levels is through a combination of regular physical activity, a healthy diet, and the relevant prescribed medication

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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Oh what a mess indeed, lots in the news to talk about as the many nations line up and pick teams for a human WW III, as history repeats itself one more time. As entire civilization prepare for war and ruin.

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