Advice Pool - Health and Fitness

Diabetic ketoacidosis is a life threatening condition that all diabetics are susceptible to and is brought on by a deficiency of insulin

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

. Type 1 diabetics are more likely to suffer from this condition, but all diabetics should be aware of its symptoms and life-threatening

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

Examples of combination products may in

affects. The mortality rate is about two percent of the people who get it.

Ketoacidosis occurs when glucose cannot be used as an energ

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

y source by the cells of the body, or when endogenous sources of energy are not available. When this happens the body will begin to brea

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

down fats and proteins for it energy source, in effect cannibalizing itself to survive. This leads to ketosis, which is an abnormal acc

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

Combination pro

umulation of ketones caused by metabolism of fatty acids for energy with little carbohydrate metabolism taking place. This can cause a r

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

apid decrease in blood pH resulting in ketoacidosis and a dumping of ketone bodies into the urine.

This condition results in hyperglyce

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

mia that causes osmotic diuresis, leads to dehydration, and precipitates lactic acidosis. Lowered pH, resulting from the acidosis, stimu

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

ates the respiratory center and produces deep, rapid respirations known as Kussmaul's respirations. Large amounts of ketone bodies in th

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

e body also produce a fruity or acetone odor on the breath. For many people unfamiliar with this condition it may actually smell as if t

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

he person has been drinking alcohol.

If the ketoacidosis in the diabetic is not recognized and treated quickly, the acidosis and dehydr

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

Following aspects would a

ation can disrupt heart activity and oxygen transport. It will also severely depress the central nervous system which leads to loss of c

dd to the challenges in developing combination products:

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

nsciousness and possibly coma and death. Other symptoms that may occur before a loss of consciousness include lethargy, nausea, muscle a

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

ches, rapid breathing (Kussmaul's respirations), low blood pressure, rapid heart rate, difficulty catching ones breath, and dehydration.

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

Other life threatening conditions brought about by this condition include kidney failure and heart attacks.

Aside from an insulin defi

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

ciency there are several other common conditions that can lead to diabetic ketoacidosis. These include over eating, infection and other

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

Professional from academic institutions, pharmaceutical industries, health care indust

tresses such as trauma, surgery, emotional stress and heart attack.

It is important for anyone with diabetes to be aware of the warning

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

signs of diabetic ketoacidosis. Consulting with one primary care physician is the first step to understanding this condition and taking

.

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

the proper steps to avoid it affects. By following a sound diabetic diet plan and treatment regiment the chances of suffering from keto

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

Companies that provide selfless information through particip

acidosis are greatly diminished. But even then anyone with diabetes should remain ever vigilant against this potentially fatal 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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