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No two people are alike and that is true of patients experiencing the stages of Alzheimer's. Alzheimer's is a form of dementia that robs one of his or he

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

r ability to reason, remember and function by slowly killing brain cells. The Alzheimer's Association has outlined seven stages of Alzheimer's based on r

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

Examples of combination products may in

search done by experts in the field. This information can guide families thorough this disease that is often difficult to understand.

Some patients may

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

kip some stages of Alzheimer's or some may be in one stage for many years. Alzheimer's patients live an average of three to 20 years after they are diagn

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

sed.

In the first stages of Alzheimer's, the patient shows no symptoms. They are functioning normally and are completing everyday activities.

In the se

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

Combination pro

ond of the stages of Alzheimer's, the patient may begin to have memory lapses. They will forget where they put the glasses, keys or shoes. Family, friend

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

and co-workers will notice this forgetfulness.

It is often not until the third stage of Alzheimer's that the symptoms really become noticeable. Unlike

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

the previous two stages of Alzheimer's, patients can no longer hide their difficulties. During the third stage, patients forget the names of family or cl

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

se friends, begin to lose their ability to plan and organize and often misplace objects. Family, friends and co-workers will notice a decline in their wo

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

k and perhaps in their social skills.

In the fourth of the stages of Alzheimer's, patients are beginning to forget current events. Simple math becomes a

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

challenge. Bills may go unpaid, housework may be neglected. At this stage of Alzheimer's patients may withdraw from social settings they once enjoyed.

I

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

Following aspects would a

the fifth of the stages of Alzheimer's, patients are more challenged by every day tasks. They may wear a fur coat in July and shorts in January. They do

dd to the challenges in developing combination products:

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

't know what day it is. They can't recall their phone number or where they went to high school.

Even though the stages of Alzheimer's and their symptoms

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

vary from person to person, by the sixth stage there is usually a noticeable decline in the patient. Many times during this stage of Alzheimer's the pati

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

ent is not aware of what is happening around them. The need help getting dressed, going to the bathroom and handling day to day activities. The patient m

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

y have delusions or hallucinations and forget the names of those around them.

It is in the very last stages of Alzheimer's that the disease is most brut

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

Professional from academic institutions, pharmaceutical industries, health care indust

l. In the seventh stage, the patient is usually totally dependent on someone else. In addition to all the changes in the previous stages of Alzheimer's t

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

e patient may lose their ability to walk, sit up or even hold their head up. They need to be fed, toileted and there is usually general incontinence. The

.

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

r speech is often unrecognizable.

A physician is the only person who can diagnose Alzheimer's disease. The family physician can also offer advice and re

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

Companies that provide selfless information through particip

er caregivers and private nurses for Alzheimer's patients. The Alzheimer's Association also provides a wealth of information on the stages of Alzheimer's

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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