Advice Pool - Health and Fitness

The type 2 diabetic condition is brought about by a diet that is too high in carbohydrates and a lack of nutrients, which results in the insu

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

lin the body naturally produces becoming less and less effective in keeping blood sugar levels under control and in a normal range.

While ch

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

Examples of combination products may in

ange in diet and proper nutritional supplementation have a dramatic effect in bringing blood sugar levels down without the need for drugs or

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

nsulin, exercise can greatly contribute to the overall control of the diabetic condition, as can be seen in the following excerpt:

"While ma

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

ny people may begin exercising out of a sense of responsibility - the way children eat vegetables they don't like - the main reason they keep

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

Combination pro

exercising is that it feels good."

"Overall, people who exercise regularly are better equipped to carry on day-to-day activities as they age

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

."

"One of the great benefits is that many people find that when they exercise, they have less desire to overeat."

"Even though your fat wo

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

't 'melt away,' exercise, particularly if you're a Type 2 diabetic, is still of value in a weight-reduction program because muscle building r

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

educes insulin resistance."

"As you increase your muscle mass, your insulin needs will be reduced - and having less insulin present in your

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

loodstream will reduce the amount of fat you pack away."

"As a result, your own insulin production gradually becomes more effective at lower

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

ing blood sugar."

excerpted from Dr. Bernstein's Diabetes Solution by Dr. Richard K. Bernstein

Higher Morning Sugar Levels?

Blood sugar

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

Following aspects would a

can be brought down and kept at normal levels throughout the day, yet, many diabetics find that even though they have not eaten before bedtim

dd to the challenges in developing combination products:

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

, when they wake up in the morning their blood sugar levels are elevated. This is caused by something called the "dawn phenomenon":

"Althoug

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

h the mechanics of the dawn phenomenon aren't yet entirely clear, research suggests that the liver deactivates more circulating insulin durin

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

the early morning hours." [This results in sugar not being pushed into cells for energy but building up in the blood instead.]

"Investigato

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

rs have actually measured blood sugar every hour throughout the night under similar circumstances. They find that the entire blood sugar incr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ase occurs about 6-10 hours after bedtime for most people who are so affected."

"Both the time it takes for blood sugar to increase and the

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

amount of the increase vary from one person to another. An increase may be negligible in some and profound in others."

excerpted from Dr. Be

.

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

nstein's Diabetes Solution by Dr. Richard K. Bernstein

You can begin maintaining healthy blood sugar levels with regular exercise combined

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

Companies that provide selfless information through particip

with a low carbohydrate diet and by supplementing with the correct nutrients. This can also help reduce the effects of the "dawn phenomenon"

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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