Advice Pool - Health and Fitness

Gestational diabetes is a condition in which a pregnant woman suffers from higher then normal blood glucose levels. Medical science does not know the exact cause

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

of this form of diabetes but many think it is linked to the stress of pregnancy on the woman's body. For the majority of women there are no noticeable symptoms of

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

Examples of combination products may in

gestational diabetes and they are unaware that they have this condition until they are tested.

It is believed that the placenta and how it works during a pregna

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

cy is the main cause for gestational diabetes. The placenta is the life support system for the baby in the uterus. During a pregnancy the placenta produces a mult

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

itude of different hormones, many of which negatively affect the effectiveness of the mother insulin. This results in high blood glucose levels because the insuli

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

Combination pro

is unable to move the glucose out of the blood and into the cells. The mother may produce up to three times her normal amount of insulin to effectively deal with

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 effects of the placental hormones. This is known as insulin resistance.

For some women they will see some of the classic symptoms that all diabetics are fam

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

liar with. These include:

• Frequent urination – Caused by high blood glucose which increases blood flow to the kidneys.

• Excessive thirst – Results from dehyd

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

ration from the increased urinary output.

• Extreme hunger – Because glucose is unable to get into the body's cells from the lack of insulin the body suffers fro

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

an energy deficit, causing hunger.

• Unusual weight loss – Despite eating more the body actually loses weight as it breaks down proteins and fats to make up for

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

the perceived energy deficit.

• Increased fatigue – Caused by the decrease in energy.

• Irritability

• Blurry vision – Caused by the increased blood volume th

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

Following aspects would a

at causes a swelling of the lens of the eye.

But the majority of women suffer no overt symptoms of gestational diabetes. Because of this it is vitally important

dd to the challenges in developing combination products:

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

hat all women be screened for gestational diabetes towards the end of the second trimester at around 24 to 28 weeks of their pregnancy.

This test is called the o

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

ral glucose tolerance test. During the test the pregnant woman will consume a drink containing 50g of glucose. After one hour her blood glucose level is tested an

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

if it is equal to or greater then 130 to 140 mg/dl then further testing is needed.

The next test to determine if a woman has gestational diabetes is the 3 hour,

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

100g oral glucose tolerance test. This test actually lasts about three days. For the three days before the test the woman eats an unrestricted diet eating at a m

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

Professional from academic institutions, pharmaceutical industries, health care indust

nimum of 150g of carbohydrates each day. The night before the test she fasts and in the morning drinks a 100g oral glucose solution. Her plasma glucose is tested

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

at four different intervals with blood glucose levels not to exceed the following for two or more of the tests:

Fasting – 95mg/dL
1 hour – 180mg/dL
2 h

.

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

urs – 155 mg/dL
3 hours – 140 mg/dL

If the diagnosis of gestational diabetes is made then the pregnant woman will have to follow a diet and exercise plan cr

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

Companies that provide selfless information through particip

eated for her individual needs by her medical care givers. For many women the first symptom of gestational diabetes is not passing the oral glucose tolerance test

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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