Advice Pool - Health and Fitness

Diabetes and psychology are not often thought of as being complimentary but with the use of psychology the life of a diab

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

etic can be drastically improved. To understand the role that psychology has to play it is first important to understand

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

Examples of combination products may in

exactly what diabetes is and how it can affect the life of a diabetic.

85% of diabetics have type 2 diabetes which is t

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

he body’s resistance to insulin. Insulin is naturally produced in the body and helps to breakdown the glucose in the bloo

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

d. The causes of type 2 diabetes are linked to obesity, inactivity and an unhealthy diet. In order to cope with diabetes

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

Combination pro

the diabetic needs to avoid long periods of high blood glucose levels called hyperglycemia and also periods of hypoglycem

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

ia which is low blood glucose levels. To balance these 2 extremes a diabetic needs to monitor and regulate their blood su

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

gar levels on a regular basis. If the diabetic doesn’t keep their glucose levels under controls they may encounter a whol

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

e host of unpleasant diseases and side effects.

The use of psychology comes in when it is necessary for a diabetic to ma

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

ke rapid and extreme changes to their lifestyle. Once diagnosed a diabetic must make these changes almost overnight so so

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

meone may go from a sedentary lifestyle of eating junk food and watching TV to having to eat regular healthy food and tak

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

Following aspects would a

e regular exercise and well as monitor their blood sugar level. This rapid change can cause lots of problems for newly d

dd to the challenges in developing combination products:

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

iagnosed diabetics.

The routines needed to monitor blood sugar levels and control the diabetes can be very complicated.

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

As the majority of diabetes treatment is self care there can be serious problems if the person lacks motivation. Their co

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

ndition can deteriorate and result in amputation of limbs or blindness. It is therefore imperative that the doctors use p

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

sychology to make the patient understand the importance of the illness.

Tests conducted in Canada and Germany into diabe

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

Professional from academic institutions, pharmaceutical industries, health care indust

tes and psychology in recent years using fully qualified psychologists have resulted in increased levels of successful di

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

abetes control. Whilst still relatively new the use of psychology has undoubted positive effects. With the current level

.

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

of 125 million diabetes sufferers estimate to double to 300 million in the next 20 years it is important that doctors st

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

Companies that provide selfless information through particip

art to realise the obvious befits of psychology and incorporate psychology as part of the treatment plan for any diabetic

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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