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Parkinsons Disease is a chronic, progressive, neuromuscular condition. It is caused by changes in the basal ganglia of the

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

brain, which manifest as disturbances of motor function distinguished by the slowing and weakening of voluntary movement, in

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

Examples of combination products may in

luding those expressing emotion.

Parkinsons Disease displays three principal characteristics, or symptoms: rigidity, brakyk

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

inesia and tremor.

Rigidity

Rigidity is caused by increased muscle tone. It often affects one hand initially, progressing

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

to one side of the body, then the other side, and finally the neck and trunk. Rigidity become more pronounced as the condit

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

Combination pro

on progresses and it also increases with anxiety and concentration. If the facial muscles are affected the individual devel

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

ops a mask-like, fixed expression with staring eyes; to the lay person, this may be the most striking symptom of Parkinsons

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

isease. In addition, handwriting may become very small and tremulous.

Bradykinesia

Bradykinesia is a slowness and poverty

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

of voluntary movement. This slowness results from muscle weakness and fatigue and is, perhaps, the most disabling feature

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

f the disease. Difficulty in initiating movement will frequently cause a delay between a stimulus, such as a request to sit

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

down, and the subsequent response. The mobility problems caused by bradykinesia include difficulties in rising from a bed o

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

Following aspects would a

r chair and in getting into or out of the bath. An interesting feature is the fact that once movement is initiated the pers

dd to the challenges in developing combination products:

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

n has less difficulty climbing a flight of stairs than walking on level ground.

Tremor

Tremor is present when the person i

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

s at rest, though not when they are asleep. It is inhibited by movement (which differs from the tremor in multiple sclerosi

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

, where tremor starts with the intention to move). It begins on one side and spreads to both sides over time.

Sensory Loss

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

and the intellect

In spite of the above symptoms there is no sensory loss associated with Parkinsons. The person who has t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he disease may often be cold because the immobility enforced by the condition makes the circulation system less responsive t

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

temperature changes. Parkinsons Disease does not normally affect the intellect, but it can slow mental processes. In addi

.

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

tion studies have shown that approximately a third of elderly people with the disease have some form of dementia. Other eff

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

Companies that provide selfless information through particip

cts may include depression, which is caused by the undermining of self-confidence brought on by the effects of the condition

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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