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Your Space - Origins Unknown-The Battle With Alzheimer's Continues
One could trace back the history of Alzheimer's disease from a presentation and lecture made by a German psychiatrist in 1906 during 37th Meeting of Southwest German Psyc
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
hiatrists held in T?bingen.
Dr. Alois Alzheimer presented his findings on a woman who had died after years of having memory problems and confusion.
When Dr. Alzheimer a
Dr. Alois Alzheimer presented his findings on a woman who had died after years of having memory problems and confusion.
When Dr. Alzheimer a
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
topsied the patient's brain, he found thick deposits of neuritic plaques outside and around the nerve cells. He also found a lot of twisted bands of fibers or neurofibril
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lary tangles inside the nerve cells.
Today, medical specialists need to find the presence of the same plaques and tangles at autopsy in order to have a conclusive diagno
Today, medical specialists need to find the presence of the same plaques and tangles at autopsy in order to have a conclusive diagno
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is that Alzheimer's disease indeed caused the disease. And due to this lecture and achievement in research and studies, the medical community has bestowed the honor of na
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ing the disease after Dr. Alzheimer.
However, Dr. Alzheimer's work only signaled the start of years of medical research and studies which could only resolve the mysterie
However, Dr. Alzheimer's work only signaled the start of years of medical research and studies which could only resolve the mysterie
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
s of the disease by so much. Up until now, Alzheimer's disease has still unknown origin and remains to have no cure. At first, the diagnosis of Alzheimer's disease was li
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
ited for individuals between the ages of 45-65 since the symptoms of pre-senile dementia due to the histopathologic process are more common and prominent during this age.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
However, during the 1970s and early 1980s, the term Alzheimer's disease began to be used to refer to patients of all ages that manifest the same symptoms.
Statistics s
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
ow that around 350,000 new cases of Alzheimer's disease are being diagnosed each year. It is estimated that by 2050, there are 4.5 million Americans afflicted by the dise
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
se. Recent studies have shown that there is an increase risk of contracting and developing Alzheimer’s as one grows older.
It has been reported that 5 percent of America
It has been reported that 5 percent of America
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ns between the ages of 65 to 74 suffer from Alzheimer’s disease. Also, half of those in the 85 years and older age group are more likely to have the disease.
Generics ha
Generics ha
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
e also been seen as a factor in the development of the disease. Scientists have found out that mutations on chromosomes 9 and 19 have been associated with the later stage
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
s of Alzheimer's. However, not everyone that manifests the mutations results to having the disease. Up until now, the relationship between genetics and late-onset Alzheim
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
r's is still a grey area.
Meanwhile, other research have associated trauma as a factor that increases the risk of acquiring the disease. There are also evidences which s
Meanwhile, other research have associated trauma as a factor that increases the risk of acquiring the disease. There are also evidences which s
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
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
ggest that lack of exercise increases the risk factor of Alzheimer's. It is important to avoid high blood pressure, high cholesterol, and low levels folate in order to de
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
crease the risk of developing the disease.
There are basically three stages of Alzheimer's disease. Stage 1 or Mild Stage is the early of the disease. At this stage pati
There are basically three stages of Alzheimer's disease. Stage 1 or Mild Stage is the early of the disease. At this stage pati
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nts become less energetic and will experience slight memory loss. Often times, the symptoms at this stage are either go unnoticed or are ignored as but trivial or normal
.
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
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
occurrences.
At Stage 2 or Moderate stage, the patient needs to be assisted in some complicated tasks and memory loss is no highly noticeable. The final stage is the sev
At Stage 2 or Moderate stage, the patient needs to be assisted in some complicated tasks and memory loss is no highly noticeable. The final stage is the sev
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
rest stage. Because the disease already progresses too far this point, the patient is unable to perform simple tasks and will lose the ability to walk or eat without help
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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