Advice Pool - Health and Fitness

Gestational diabetes (GD) is when a pregnant woman that previously was not diabetic becomes diabetic. It generally only lasts during pregnancy. It is also known by the

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

term glucose intolerance of pregnancy. GD is like type 2 diabetes in that the body becomes resistant to insulin. It does not stop producing insulin but the body simply

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

Examples of combination products may in

inds the insulin ineffective or it is not produced in sufficient quantity. Whilst it is not completely understood how this occurs in pregnant women the current thinking

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

is that hormones that are secreted during pregnancy act as a blocking agent to insulin hence causing insulin resistance.

Symptoms of Gestational Diabetes

It is often

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

quite hard to detect the disease because the body is undergoing dramatic changes all the time, many of which a being experienced for the first time. A pregnant woman wi

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

Combination pro

ll be in contact with her doctor frequently during the pregnancy so it is a good idea to mention any unusual changes in the body. Generally the condition will affect wo

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

en in the latter stages of pregnancy (around 24-28 weeks). A classic symptom of gestational diabetes is excessive thirst or polydipsia. This could be accompanied by fre

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

quent urination (polyuria).

Other symptoms for gestational diabetes include :

Fatigue

Nausea

Blurred vision

Bladder or yeast infection.

As you can see, these symp

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

oms could be the result of normal changes during pregnancy so it is important to keep your doctor informed so that he/she can screen you for gestational diabetes.

Trea

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

tment of Gestational Diabetes

The aim of treating the disease is to keep the blood sugar levels within a normal range. This will be determined by your doctor after a t

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

st to confirm that you have diabetes. Treatment will involve :

A gestational diabetes menu plan

This will be worked out with your doctor or ,more likely, a dietitian.

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

Following aspects would a

A gestational diabetes diet will factor in your size, age and stage of pregnancy when creating a meal plan for you. In principle, the foodstuffs used will be split int

dd to the challenges in developing combination products:

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

:

carbohydrates,

vegetables and fruits,

meat or meat substitutes (protein),

milk and diary products,

sweets, candy and oils (fats)

More information can be found

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

on how to use these food groups by following the diabetic food pyramid. By following a meal plan for gestational diabetes you will limit the amount of sugar that enters

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

you bloodstream. This will help to control the blood sugar level.

Another essential part of treating GD is a regular exercise plan. This might involve a daily walk or

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

some light exercise. Exercise will burn up sugar in the blood so that the blood sugar level does not get high.

If a diet and exercise are not sufficient in keeping the

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

Professional from academic institutions, pharmaceutical industries, health care indust

sugar level within a safe range, your doctor may prescribe a drug, such as Glyburide, to help make the body less resistant to insulin or insulin injections.

A complica

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

tion of Gestational Diabetes , if left untreated, is that the baby will be larger than normal (known as Macrosomia). This occurs because there is an increase in the blo

.

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

d glucose levels and insulin production that stimulate the growth of the fetus. This may result in a cesarean section during birth.

Gestational diabetes usually stops

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

Companies that provide selfless information through particip

after birth but it has been found that women that had GD are more likely to develop diabetes mellitus in the proceeding years than women that did not have the condition

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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