Advice Pool - Health and Fitness

Studies show that up to five percent of the world’s population suffer from diabetes in some form. In fact, an estimated 11 mil

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

lion people in Western Europe alone are reported to be diabetics. And yoga has shown to offer beneficial results in curing dia

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

Examples of combination products may in

etes.

Noninsulin-dependent diabetes mellitus (NIDDM) is probably the most common form of diabetes found today out of the many

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

different ways in which diabetes presents itself. And NIDDM or Type II diabetes is known as multi-factorial, dependent on env

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

ronmental factors as well, like sedentary lifestyles, obesity and negative nutritional issues.

Yoga exercises that many presc

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

Combination pro

ribe for helping to heal diabetes are different from basic yoga exercise style as it involves positions tailored to treat cert

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

in conditions, as well as relaxation, meditation and stretching exercises.

Case Study

The Yoga Biomedical Trust, founded in

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

1982 by biochemist Dr Robin Monro and an Indian yoga research foundation, discovered that if people practiced yoga for 30 minu

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

es a day for one full month, the activity helped reduce blood glucose levels in some diabetics.

One of the studies conducted

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

to cure diabetes was the one set up where yoga patients participated in one or two 90-minute weekly sessions for 12 weeks. Par

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

icipants worked out with certain yoga classes in their homes; including the bow, the spinal twist and some abdominal breathing

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

Following aspects would a

Near the close of the session, the participants’ blood sugar levels decreased greatly across the board and were only somewha

dd to the challenges in developing combination products:

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

t elevated in the control group, a group who had not participated in the yoga sessions. Notable also was that three yoga stude

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

ts were even able to reduce their own medications they’d been on, including a person who had been on the same drug regime for

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

nearly 20 years.

In summary, medical science has known for quite awhile that exercise is very helpful for diabetics. And the

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

bility of yoga therapy to help lower stress levels may play a part in maturity onset diabetes. However, some patients might fi

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd it hard to keep up the regular sessions necessary to reap the full benefits. And many wouldn’t have the money needed for or

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

means to get out to continuing yoga classes.

Note also that you do not need classes outside the home to put yoga into practic

.

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

e. What are important are the techniques, the actual physical exercise itself and the overall benefits – both physically and m

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

Companies that provide selfless information through particip

ntally - from the stabilization that yoga brings about. These are all factors that can help improve the health of the diabetic

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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