Advice Pool - Health and Fitness

Dementia is the progressive decline in cognitive function due to damage or disease in the brain beyond what might be expected from normal aging

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

. Particularly affected areas may be memory, attention, language and problem solving, although particularly in the later stages of the conditio

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

Examples of combination products may in

n, affected persons may be disoriented in time, not knowing what day, week, month or year it is, not knowing where they are not knowing who the

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

y are.

Symptoms of dementia can be classified as either reversible or irreversible depending upon the etiology of the disease. Less than 10% o

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

f all dementias are reversible. Dementia is a non-specific term that encompasses many disease processes, just as fever is attributable to many

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

Combination pro

etiologies.

Early symptoms of dementia often consist in changes in personality, or in behavior. Often dementia can be first evident during an

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

episode of delirium. There is a higher prevalence of eventually developing dementia in individuals who experience an acute episode of confusion

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

while hospitalized.

Dementia can affect language, comprehension, motor skills, short-term memory, ability to identify commonly used items, rea

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

ction time, personality traits, and executive functioning. Even without signs of general intellectual decline, delusions are common in dementia

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

(15-56% incidence rate in Alzheimer's type, and 27-60% incidence rate in multi-infarct dementia). Often these delusions take the form of monot

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

hematic delusions, like mirrored self-misidentification.

Elderly people can also react with dementia-like symptoms to surgery, infections, sle

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

Following aspects would a

ep deprivation, irregular food intake, dehydration, loneliness, change in domicile or personal crises. This is called delirium, and many if not

dd to the challenges in developing combination products:

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

most dementia patients also have a delirium on top of the physiologial dementia, adding to the symptoms.

The delirium can go away or greatly

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

improve when treated with tender care, improved food and sleeping habits, but this does not affect the alterations in the brain. Affected perso

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

s may also show signs of psychosis or depression. It is important to be able to differentiate between delirium and dementia.

Proper differenti

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

al diagnosis between the types of dementia will require, at the least, referral to a specialist, e.g. a geriatric internist, geriatric psychiat

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

Professional from academic institutions, pharmaceutical industries, health care indust

rist or neurologist. However, there are some brief 5-15 minute tests that have good reliability and can be used in the office or other setting

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

to evaluate cognitive status.

Except for the treatable types listed above, there is no cure to this illness, although scientists are progressi

.

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

ng in making a type of medication that will slow down the process.

Disclaimer - The information presented here should not be

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

Companies that provide selfless information through particip

interpreted as medical advice. If you or someone you know suffers from Dementia, please consult your physician for the latest treatment options

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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