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Advice Pool - Diabetes Mellitus: How Do I Get It?
Diabetes Mellitus is a group of chronic disorders that are caused by a minor or total insulin deficiency.
Although there a
Although there a
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
re genetic factors to it, developing the disease also depends greatly on environmental factors.
It affects over 130 millio
It affects over 130 millio
; 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
n people worldwide. In America, 1 in every 20 people has diabetes.
The disease itself must be managed through monitoring a
The disease itself must be managed through monitoring a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d maintaining proper blood sugar levels through a healthy diet and regular exercise.
It is a disease that weakens the vasc
It is a disease that weakens the vasc
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ular system and causes many complications, such as loss of eye sight or kidney damage.
For every one patient that is diagn
For every one patient that is diagn
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
osed with this disease, there is another who is not.
The complications of those who have not received, or ignore their dia
The complications of those who have not received, or ignore their dia
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
etic diagnosis, at times overwhelm the medical community and it is also the disease that has the most financial impact on t
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
he economy at 100 billion dollars per year.
Diabetes is divided into two major groups. The first group, known as Primary D
Diabetes is divided into two major groups. The first group, known as Primary D
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
iabetes Mellitus, covers the most commonly known types of diabetes:
• Type 1 – this is an insulin dependent type of diabet
• Type 1 – this is an insulin dependent type of diabet
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
s
• Type 2- this is a non-insulin dependent type of diabetes
• Type 3- this is a malnutrition related type of d
• Type 2- this is a non-insulin dependent type of diabetes
• Type 3- this is a malnutrition related type of d
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
iabetes, not commonly discussed
• Gestational Diabetes- this a type of diabetes that develops in women during pregnanc
• Gestational Diabetes- this a type of diabetes that develops in women during pregnanc
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
y
The second group of diabetes is known as Secondary Diabetes Mellitus.
These types of diabetes are caused by outside fac
The second group of diabetes is known as Secondary Diabetes Mellitus.
These types of diabetes are caused by outside fac
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
ors other than genetics and environmental factors.
When things like acute or chronic pancreatitis or pancreatic cancer des
When things like acute or chronic pancreatitis or pancreatic cancer des
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
troys the pancreas- which is the insulin producing organ in the body- secondary diabetes will occur.
Chronic liver disease
Chronic liver disease
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
like in Hemochromatosis, endocrine abnormalities like in Hyperthyroid and Cushing syndrome are very common.
The use of
The use of
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
medications to treat other conditions can all bring about a diagnosis of secondary diabetes.
Genetic disorders, like Down
Genetic disorders, like Down
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
syndrome is involved in diabetes.
The main abnormality with diabetes is the difficulty of having to control blood sugar. I
The main abnormality with diabetes is the difficulty of having to control blood sugar. I
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nsulin is produced in the pancreas and its function is to control your blood sugar in a narrow range. In type I diabetes we
.
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
find that there is not enough insulin production. In type II diabetes, most of the time we find enough insulin but it is no
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
t available to control the sugar levels. Both the above situations lead to a rise in blood sugar and further on to diabetes
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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