Advice Pool - Health and Fitness

Gestational diabetes is a type of diabetes that develops in pregnant women in 2-3% of pregnancies. For whatever reason, the blood suga

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

r levels become abnormal during pregnancy due to a mild or sometimes severe carbohydrate intolerance. The potential for fetal and neon

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

Examples of combination products may in

atal loss is higher in this category and is therefore an area of great concern. Proper prenatal care allows for many complications to

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

be avoided. Gestational diabetes requires a good amount of medical attention. There may be several doctors involved when dealing with

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

his type of diabetes.

Despite the fact that gestational diabetes will generally clear up in the majority of women after the delivery

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

Combination pro

of the child, it also means that the chance for these women to develop diabetes mellitus within the next 15-20 years increases by 50%.

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 risk of complications is high with gestational diabetes. They can include pre-term labor, pregnancy induced hypertension, infect

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

ons or delivery problems. This makes proper prenatal care a must.

Those at risk for gestational diabetes include women who:

• have h

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

ad multiple pregnancies

• have had previously unexplained stillbirths

• have given birth to babies 9 lbs or more

• have gained an e

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

xcessive amount of weight during pregnancy

• come from a high risk ethnic groups such as Hispanic, Native American or African America

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

• have a previous history of high blood sugar or previous pregnancies with gestational diabetes

• have a family history where their

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

Following aspects would a

mother or sisters had gestational diabetes

As with other types of diabetes, good control of blood sugar levels are the key to managi

dd to the challenges in developing combination products:

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

ng gestational diabetes properly. A proper diet and watching weight gain while keeping regular appointments with health care professio

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

nals is key to ensuring the baby’s safety during its 9 month gestation period. Most women who actively participate in the proper manag

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

ment of their gestational diabetes go into labor at term and deliver naturally.

That which is affecting the mother during pregnancy w

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

ill also affect the baby. When blood sugar levels stay above normal, the fetus’ pancreas will in turn put out more of its own insulin

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

Professional from academic institutions, pharmaceutical industries, health care indust

to help control its own blood sugar levels. What can happen in these types of incidences is that the insulin will act as a growth horm

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

ne and increase the baby’s size. The result is macrosomia, a term that means ‘large body’. This can cause trouble as far as delivery i

.

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

s concerned. These complications can be prevented with proper prenatal care.

Gestational diabetes is a big fear of most pregnant wome

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

Companies that provide selfless information through particip

n and it can be less of a problem with the right knowledge. Always keep your weight gain under control and visit your doctor regularly

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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