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Dementia is defined as a clinical syndrome characterized by a loss of previously acquired intellectual function. It is

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

generally associated with the elderly, but some dementias, such as Alzheimers, can start in middle life. The latter dis

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

Examples of combination products may in

rder was originally described by Alois Alzheimer (a German psychiatrist) in 1907 as a condition that developed before th

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

age of 65. This early form of Alzheimer's is now known as Type 2, while that which develops after age 65 is known as T

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

pe 1.

The features of dementia

There are three key features of dementia which are generally recognized. The fi

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

Combination pro

st is a loss of general intelligence marked by impairment in abstract thinking, judgment and problem solving abil

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

ty. Thinking can be slow and inflexible and the ability to reason logically can be reduced.

The second is a persona

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

lity change, where behavior becomes rude, tactless and generally insensitive to the feelings of other people. Perso

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

ality changes are often described as 'coarsening', since they reflect exaggerations of the less desirable aspects of 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

person's character which have previously been kept under restraint.

The third change is related to emotional well-be

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

ng. There is often depression, anxiety or irritability, especially in the early stages when the person still has so

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

Following aspects would a

e degree of insight into their failing intellectual powers. In the later stages the emotions tend to become blunted and

dd to the challenges in developing combination products:

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

the person no longer appears to be capable of responding to events in their environment.

Senile Dementia

Senile

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

dementia is the most common and important form of dementia of the Alzheimer type. The incidence of senile dementia incr

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

eases with age: 0.4% of the population at 70 years, rising to 5.2% at 90 years. It is important to realize Alzheimers d

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

es not simply describe a 'normal' pattern of aging and neuropsychological tests can demonstrate this.

Unfortunately, th

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

Professional from academic institutions, pharmaceutical industries, health care indust

course of senile dementia is one of relentless decline. The person becomes more helpless and prey to infection, partic

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

larly bronchopneumonia, which is the commonest cause of death in people suffering from senile dementia. Back in the 195

.

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

s most people with senile dementia were dead within two years of admission to hospital. However, this figure has progre

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

Companies that provide selfless information through particip

sively extended as patients have been given better care and they now tend to be admitted to hospital at an earlier stage

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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