Advice Pool - Health and Fitness

Diabetes type 2 also known as non-insulin dependent diabetes mellitus is a chronic disease which appears when the insulin produced by the pancreas can not reduce the blood level of glucose. Sometimes diab

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

etes appears when insulin is not produced in a sufficient quantity by the pancreas. The role of insulin is to take the glucose from the blood and lead it inside the body cells which use it to produce ener

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

Examples of combination products may in

y. If the level of glucose is too high in blood it will be eliminated by the kidneys in urine.

Diabetes type 1 is known to occur during childhood and was named as insulin-dependent diabetes mellitus. The

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

pancreas is not able to produce the insulin any more as the cells responsible to this process have been destroyed by the body. These patients require insulin injections permanently.

Diabetes type 2 occur

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

mostly during adulthood and is found in 90% of the diabetic patients. In this case the insulin is not produced in sufficient quantities or it is not effective on the body cells. This type of diabetes occ

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

Combination pro

rs mostly in obese people and in those who have high levels of cholesterol in blood. Elder people can get affected of this type of diabetes too.

There is another type of diabetes called the gestational d

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

abetes which sometimes occurs in women who are pregnant.

Genetics and family history also have an important role in determining whether diabetes type 2 will install or not. Also, having a sedentary lifes

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

yle, eating junk food will only increase the risk of developing this affection.

Some other risk factors are: the age over 45, high blood pressure, HDL less than 35 mg/dl, triglycerides more than 250 mg/d

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

and a previous history of personal impaired glucose tolerance.

Most of the diabetes type 2 cases do not present any symptoms at all. In some cases increased thirst, appetite and urination might occur al

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

ng with blurred vision, fatigue, infections, and erectile dysfunctions.

Diagnosing diabetes is made after the doctor sees the results of some tests. He will ask for fasting blood glucose level (it has to

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

be higher than 126 mg/dl in order for the patient to have diabetes); non-fasting blood glucose level which leads to a suspicion of diabetes if higher than 200 mg/dl and along with symptoms of increased th

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

Following aspects would a

irst, urination, and fatigue; and positive oral glucose tolerance test (if found higher than 200 mg/dl after 2 hours).

The treatment of diabetes focuses on eliminating the symptoms and keeping the blood

dd to the challenges in developing combination products:

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

lucose levels under control.

At first the doctor will recommend the patient to exercise daily and to keep a diet. Also, monitoring regularly the level of glucose in blood is essential for further treatme

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

t measures. If weight is being reduced type 2 diabetes can be managed quite easily along with keeping a diet and exercising. The doctor will help the patient to test his level of glucose in blood by its o

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

n; will let him know what he is allowed to eat and what he must avoid; will advise him what to do when he feels sick and will tell him where he can procure his diabetes supplies.

Testing the level of glu

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

ose in blood can be done by the patient without the doctor's help. These tests are usually done before meals and at bedtime. The patient will monitor its level of glucose in blood with the help of a gluco

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

Professional from academic institutions, pharmaceutical industries, health care indust

eter. This device shows quickly the results, in about 30 seconds. All the patient needs to do is prick his finger with a small needle attached to the glucometer and a drop of blood will appear on the fing

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

r. This drop of blood will be then placed on the glucometer's test strip and the results will appear in no time. By keeping a record of the values obtained in several days by the glucometer the doctor wil

.

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

be able to set a more adequate treatment scheme for the patient.

Keeping a diet is very important along with exercising as it can help the overweight patient reach a satisfying weight and reduce the glu

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

Companies that provide selfless information through particip

ose level in blood in this way. The diet will be also set by the doctor and a nutritionist who will choose healthy foods for the patient, in adequate amounts, and will also set a schedule for taking meals

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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