Advice Pool - Health and Fitness

Diabetes is a disease that if left untreated will lead to a wide range of complications involving a variety of bodily organs and systems. These complications are all ver

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

y serious and can be crippling or deadly. For the diabetic the best way to prevent or minimize any disorder arising from their disease is through proper management of th

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

Examples of combination products may in

ir disease. This is accomplished through lifestyle changes involving diet, exercise, medication and regular visits to the doctor.

The primary cause for many of these co

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

plications revolves around high blood glucose (sugar) levels and the damage that it causes.

1. Diabetic Retinopathy – This condition involves the retina of the eye. The

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

capillaries of the retina undergo changes that lead to decreased blood flow, known as ischemia. This leads to the presence of exudates or fluid in the eye, "cotton wool

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

Combination pro

patches on the retina, and a build up of fibrous tissue. This will result in vision impairment and even blindness if the diabetes is not properly managed. There is also

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

an increased risk of cataracts due to high levels of glucose in the lens of the eye.

2. Diabetic Ketoacidosis – This is primarily a condition that is specific to type 1

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

diabetes. It occurs when there is an insulin deficit and glucose can not enter the cells to be used for energy. The body responds by metabolizing fat and protein which

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

auses blood pH to drop and the dropping of ketone bodies into the urine. This affects respirations, which can have a fruity smell, disrupts heart function, depresses the

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

central nervous system, drops blood pressure, and a number of other symptoms which can lead to coma and death.

3. Diabetic Neuropathy – Neuropathy is a deterioration or

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

loss of nerve function. It is caused primarily by a thickening of the blood vessels that supply the nerves with nutrients. The symptoms first start in the toes and feet

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

Following aspects would a

and work their way up to the rest of the body.

4. Diabetic Nephropathy – A disorder of the kidneys, diabetic nephropathy affects about 20 to 40 percent of all diabetics

dd to the challenges in developing combination products:

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

Although the exact cause is unknown it is believed that high glucose causes damage glomerulosclerosis which affects the filtering function of the kidneys. This disease

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

s usually accompanied by high blood pressure which needs to be aggressively treated.

5. Diabetic Hypoglycemia – Also known as low blood sugar this condition is common i

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

n those who have type 1 diabetes. It will occur in type 2 diabetics who are taking oral hypoglycemic medications. The symptoms, which include dizziness, lightheadedness,

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

loss of consciousness and in severe cases coma and death are a result of a lack of glucose needed for proper brain function.

6. Diabetic Cardiovascular Disease – Diabet

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

Professional from academic institutions, pharmaceutical industries, health care indust

s causes a variety of changes to the cardiovascular system of it sufferers including atherosclerosis, structural defects in the blood vessels and thickening of capillary

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

basement membranes. All of this can lead an increased risk of coronary artery disease, high blood pressure, stroke, and peripheral vascular disease.

Diabetes is a dise

.

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

se that affects all ages and types of people. Its effects can be devastating if not treated in a timely and appropriate manner. Left untreated it can cause serious healt

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

Companies that provide selfless information through particip

problems and even death. Everyone needs to be aware of this diseases and how some simple lifestyle changes can make the difference in the lives who suffer from diabetes

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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