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E-Articles - Most Type II Diabetes is Preventable
Several recent studies show that most cases of Type II
diabetes can be prevented with th
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
e diabetic medications,
metformin, Avandia or perhaps Actos (Lancet, September
; 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
29,
2006; Diabetes Care, Volume 29, 2006). An earlier study
showed that lif
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
style changes were even more effective in
preventing diabetes than drugs (Annals of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Pharmacotherapy,
July 2004).
People most likely to develop diabetes have a family
People most likely to develop diabetes have a family
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
history of diabetes, are overweight, and store fat primarily in the
belly, rather than
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
the hips. They often have a thick neck, male
pattern baldness, high blood levels of tr
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
glycerides and low levels
of the good HDL cholesterol, and do not exercise. Pre-diabete
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s
is defined as having a fasting blood sugar greater than 100 but
less than 125, a one
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
hour-after-eating blood sugar greater than
160 but less than 200, and an HBA1c greater t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
han 5.7 but less
than 6. (HBA1c is a blood test that measures how much sugar is
stuck
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
on cells).
If pre-diabetics take medications used to treat diabetes, or change their li
If pre-diabetics take medications used to treat diabetes, or change their li
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
estyles, they markedly reduce their chances of
going on to develop diabetes. Both the pr
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
evention and treatment
of diabetes involves preventing blood sugar levels from rising to
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
high after meals. To do this, a person should avoid the foods
that cause the highest
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
rises in blood sugar levels, such as those
made from flour, those with added sugar, and
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
sugar water found
in fruit juices and many soft drinks. Other recommendations are
to
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lose weight, exercise, and eat fewer calories.
If you fit the description of a person a
If you fit the description of a person a
.
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
risk for diabetes, check with your
doctor and get a blood test called HBA1C. If the va
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
lue is greater
than 5.6, you should start your diabetic prevention regimen
immediately
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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