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Advice Pool - Why High Blood Sugar is Dangerous, Even if You Aren't Diabetic
We’ve known for years that high blood sugar is a health risk for people with diabetes. In diabetics, a high average blood sugar lev
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
el increases the risk for blindness, kidney disease and nerve damage. It also increases the risk of heart disease, which accounts f
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
or 80% of deaths in people with diabetes.
A study conducted at the University of Cambridge School of Clinical Medicine recently di
A study conducted at the University of Cambridge School of Clinical Medicine recently di
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
scovered that non-diabetics are also at much higher risk of heart disease and other fatal illnesses if their blood sugar levels are
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
above normal.
This gives us one more reason to lose weight and cut back or eliminate the sugar from our diets. It isn’t just about
This gives us one more reason to lose weight and cut back or eliminate the sugar from our diets. It isn’t just about
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
losing weight to look better - it’s about staying healthy.
A study headed by Kay-Tee Khaw, M.D., was published in the September 2
A study headed by Kay-Tee Khaw, M.D., was published in the September 2
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
1, 2004 issue of Annals of Internal Medicine.
It was discovered that for both men and women, even those without diabetes, there is
It was discovered that for both men and women, even those without diabetes, there is
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
a strong relationship between high average blood sugar levels and cardiovascular disease. In fact, high blood sugar levels appear t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o be a risk factor for deaths from all causes.
The high-blood sugar risk was found in people with moderately elevated average bloo
The high-blood sugar risk was found in people with moderately elevated average bloo
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
d sugar levels that are almost "normal" for Americans.
Three-fourths of the 521 deaths from all causes among study participants we
Three-fourths of the 521 deaths from all causes among study participants we
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e people with moderately elevated average blood sugar levels between 5% and 6.9%. Those with the lowest rates of heart disease and
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
death had blood sugar levels below 5%, as measured by a test called hemoglobin 1c (HbA1c).
Every 1% increase in the blood sugar le
Every 1% increase in the blood sugar le
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
vel increases the risk of death -from any cause - by 28% for women and 24% for men. These risks were independent of other risk fact
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ors, including age, body mass index (BMI), systolic blood pressure, cholesterol counts, smoking, or history of heart disease.
How
How
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ignificant are these findings for the average American? With every small increase in the average blood sugar level, even as small a
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
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
n increase as 0.1%, the risk of heart disease goes up. And only about 1/4 of our general population has average blood sugar levels
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
in the safe 5% range. Unfortunately, the tendency is for our blood sugar levels to keep going up, as our obesity rate increases and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
our activity levels decline.
As we put on more fat, our bodies are less able to remove excess sugar from the blood, because those
As we put on more fat, our bodies are less able to remove excess sugar from the blood, because those
.
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
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
extra fat cells cause a lowered insulin response. Overweight people are especially prone to high blood sugar levels, so a diet high
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
in veggies and fruit, instead of sugar and simple carbs, is even more important for those of us who are carrying some extra weight
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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