Advice Pool - Health and Fitness

The genetics of diabetes are very complex, but before I delve into that, you need to be aware that the terminology

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

has changed. What used to be called Juvenile Diabetes is now called type 1. What used to be called Adult Onset

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

Examples of combination products may in

iabetes is now called type 2, as you note. The reason for no longer using the terms Juvenile and Adult Onset 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.

at both Juvenile and Adult Onset Diabetes occur throughout the life span. Thus, the old terms are misleading.

Typ

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

1 and type 2 are completely different conditions which share a common clinical end result, elevated blood glucose

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

Combination pro

levels. Actually type 2 and 1 are really families of diseases, but we'll leave that complication out for simplici

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

y's sake.

Yes, diabetes of both types can run in families and there is a genetic component to the diseases which

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

may, or may not, be inherited. On the other hand, the majority of diabetics, of either type, do not have a first

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

egree relative with the disease. The genetic predisposition to diabetes is fairly easy to come by. In both cases

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

there are probably many contributing genetic locations and the probability you will get the disease depends on wh

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

ch subset of the locations that have the disposing characteristic a particular individual winds up possessing. Th

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

Following aspects would a

re also appear to be some genes which protect from the disease. The general picture of the onset of diabetes is th

dd to the challenges in developing combination products:

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

t you have a genetic predisposition which is then triggered by some environmental factor. Beyond this very genera

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

picture the two types start becoming distinct.

The probability that an individual with a type 1 sibling will dev

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

elop type 2 diabetes is the same as in the general population, since they are independent conditions. The estimat

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

s of the risk of type 2 vary quite a bit for a couple reasons. Type 2 incidence rises very steeply with age and so

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

Professional from academic institutions, pharmaceutical industries, health care indust

any age cut off in your sample has a dramatic effect on the cumulative incidence. Rates also vary widely dependin

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

on the details of the population you look at. Lastly, much of the type 2 diabetes remains undiagnosed, so your c

.

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

lculated rate depends heavily on your estimate of the undiagnosed population. In round numbers, the risk of being

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

Companies that provide selfless information through particip

iagnosed with type 2 diabetes during a 70 year life is 10%. The risk of contracting type 2 is close to twice that

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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Advice Pool - Is Juvenile Diabetes Hereditary?

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