Advice Pool - Health and Fitness

There are two important issues regarding diabetes and pregnancy. The first concerns the diabetic who wants to conceive and carry a healthy baby to full term and delivery (

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

pre-existing diabetes). And the second issue involves the development of gestational diabetes in a woman who previously showed no sign of the disease.

For the first issue

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

Examples of combination products may in

: It is important that any woman with pre-existing diabetes, who either wants to conceive or finds herself pregnant, strictly control her glucose levels, this is particula

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

rly important in the early months of pregnancy. The risks of serious birth defects are increased by poor control of pre-existing diabetes, and it is also suggested to be a

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

major cause of miscarriage.

Those women who develop gestational diabetes usually have no increased risk for birth defects although it is important that glucose levels be

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

Combination pro

carefully monitored and controlled to reduce the risk of stillbirth.

All female diabetics who are pregnant tend to deliver much larger babies than the average. It is know

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

n that the babies grow larger because some of the additional sugar from the mother passes through the umbilical cord into the blood stream of the baby. Insulin then conver

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

ts this sugar into fat cells. In many cases, these large babies have to be delivered by caesarian section as they are too large for a vaginal delivery.

Provided diabetes

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

is properly controlled there is no reason why diabetic women should not enjoy uncomplicated pregnancies and deliver healthy babies. It is when the diabetes is not controll

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

ed that complication can happen. Unfortunately, these complications can lead to miscarriage, high blood pressure, premature delivery, and stillbirth.

Pregnant women who h

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

ve pre-existing diabetes are given a blood test to measure the level of glycosylated haemoglobin before conception. This blood test provides an accurate measure of how wel

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

Following aspects would a

l glucose levels have been controlled in the preceding months, and it can indicate the safest time to conceive. This test can also be used throughout the pregnancy to meas

dd to the challenges in developing combination products:

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

ure how well the diabetes is being controlled.

The current recommendation is for all women to take folic acid before conceiving to avoid the baby developing with neural t

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

ube defects. This advice is particularly important for diabetic women as diabetes can increase the risk of this type of birth defect.

Currently, oral medications used to

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

control type 2 diabetes are not approved for use during pregnancy. For this reason, women who are using these drugs will need to switch to insulin before conceiving and du

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

ing pregnancy.

Most pregnant women are tested for gestational diabetes at some stage between the 24th and 28th week of pregnancy. Those who develop this gestational diabe

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

Professional from academic institutions, pharmaceutical industries, health care indust

tes normally discover that blood glucose levels return to normal after the birth of the baby.

Moderate exercise is believed to help cells make better use of available ins

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

ulin and is recommended during pregnancy.

Blood sugar levels must be monitored carefully during pregnancy as insulin requirements can vary significantly from those requir

.

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

ed before conception. Urine can also be checked for ketones as the presence of these can be an indication that the diabetes is not being adequately controlled.

For both t

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

Companies that provide selfless information through particip

he safety of the mother and the baby, it is important that all precautions be taken when diabetes is found in the mother. Failure to do so can lead to devastating problems

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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