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Advice Pool - Pre-Diabetes - Why It Is Important To Have Good Information
It's official! - according to the Center for Disease Control (CDC) type 2 diabetes has now reached epidemic proportions and that
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
means that there are millions of people going about their normal day-to-day business not just with type 2 diabetes but, more im
; 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
portantly, with diabetes which is in its early stages of development or with undiagnosed diabetes.
Early stage type 2 diabetes,
Early stage type 2 diabetes,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
during which blood sugar levels are raised but are not elevated enough to warrant a formal diagnosis of diabetes, is known as pr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e-diabetes. Pre-diabetes is currently estimated to affect over 50 million Americans.
At this stage of the disease it is often f
At this stage of the disease it is often f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lt that diabetes is of little concern, but studies show that, even at this early stage, permanent long-term damage is occurring,
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
particularly within the circulatory system and the heart.
As pre-diabetes does not have any symptoms, the only way to know if
As pre-diabetes does not have any symptoms, the only way to know if
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
ou are suffering from it is for your doctor to test for the presence of the disease. Now, since we clearly can't begin testing t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he population as a whole this leads to the question of just who is most likely to be at risk from pre-diabetes.
If you are over
If you are over
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
the age of 45 and are overweight (even modestly overweight) then you should consider asking for a test. If you are under the age
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of 45 and are again overweight then testing may also be advisable but, in this case, you should talk this over with your doctor
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
and be guided by his advice.
Testing is a quite simple process using one of two standard tests – a fasting plasma glucose test
Testing is a quite simple process using one of two standard tests – a fasting plasma glucose test
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
or an oral glucose tolerance test. Both of these tests will show whether your blood glucose levels are normal, pre-diabetic or d
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
iabetic.
Fortunately, if the test indicates that you are pre-diabetic then returning your blood glucose levels to normal and de
Fortunately, if the test indicates that you are pre-diabetic then returning your blood glucose levels to normal and de
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
aying the onset of diabetes is normally quite easy.
A simple diet and exercise program, combined if needed with a modest weight
A simple diet and exercise program, combined if needed with a modest weight
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
loss, can often return blood glucose levels to normal fairly quickly and, if you maintain a healthy diet and an exercise progra
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
, your blood glucose level should not remain at normal levels for a long time. This does not mean that you will eliminate the ri
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
sk of developing type 2 diabetes altogether, but it does mean that you can delay its onset and, most importantly, prevent early
.
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
nd irreparable damage to your circulatory system and heart.
Pre-diabetes is a serious condition but it is both easy to detect a
Pre-diabetes is a serious condition but it is both easy to detect a
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
nd simple to treat. The only thing that we really need to knock pre-diabetes on the head is a better program of public awareness
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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