Advice Pool - Health and Fitness

Gestational diabetes is a common condition of pregnancy where a woman has high blood sugars during the pregnancy but didn’t have high blood sugars befo

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 becoming pregnant. It can often mean, however, that a woman is prone to diabetes in her future but this is not universal.

Most women find out they

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

Examples of combination products may in

have gestational diabetes because they have a special test done in diabetes called a one hour glucose tolerance test or “1 hr GTT”. This involves drin

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

king around 50 grams of glucose in the doctor’s office. The blood sugar is tested one hour after drinking the liquid. If this test is elevated furthe

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

tests are performed to confirm the diagnosis of gestational diabetes.

Women with gestational diabetes normally just need to watch their weight gain a

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

Combination pro

nd their sugar intake while the doctor does closer monitoring of the pregnancy. Very rarely, the woman will need to take insulin during the pregnancy

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

o keep the blood sugar down.

The biggest complication of gestational diabetes is that of having infants which are larger for their gestational age. L

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

arge babies have a higher incidence of having to be born by Cesarean section and there is a higher risk of birth trauma or complications. Just because

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

the infant is big doesn’t mean the infant is mature. The baby can weigh ten pounds but still be born with immature lungs.

There are more problems wit

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

h the pregnancy in gestational diabetes. Frequent tests called fetal non-stress tests must be done to make sure the baby is still healthy. Anytime th

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

non-stress test is not showing normal fetal activity, the infant may have to be delivered early, even if he or she is not particularly full term yet.

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

Following aspects would a

After the pregnancy complicated by gestational diabetes, the infant can have problems with very low blood sugar. This is because its pancreas has bee

dd to the challenges in developing combination products:

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

putting out insulin in high amounts during the pregnancy—amounts of insulin that are not needed after the baby is born. The blood sugar can become so

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

dangerously low that the baby will need to have intravenous sugar for a period of time until the pancreas settles down. In milder cases, the blood su

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

ar is monitored carefully while the infant is fed formula as early as possible to bring the blood sugar up.

Babies born from mothers with gestational

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

diabetes will have a higher risk for breathing problems after birth. After a few days of oxygen and monitoring, the baby generally resolves without in

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

Professional from academic institutions, pharmaceutical industries, health care indust

ident. As the baby is born fat, it is at risk for developing obesity of childhood and all of the complications that go with that. As adults, these ch

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

ildren are at risk for developing gestational diabetes or type II diabetes themselves.

Once a woman has gestational diabetes, she is at risk for devel

.

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

ping the condition again. She is also at risk for developing type II diabetes. If she gets pregnant without controlling her type II diabetes, there i

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

Companies that provide selfless information through particip

s a higher risk of birth defects in the developing infant who was exposed to higher than normal blood sugars during key stages of embryonic development

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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