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The Central and Peripheral nervous system consists of three parts: the brai

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

n and the spinal cord-often spoken of together as the central nervous syste

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

Examples of combination products may in

m; the nerves which proceed from the brain and spinal cord-forty-three in n

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

mber on each side-named the cerebrospinal or peripheral nerves; the third p

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

art consisting of a number of ganglia-containing nerve cells, which are pro

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

Combination pro

usely connected by plexuses of nerve fibres, and are situated in the neck,

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

thorax, and abdomen. The part is known as the autonomic nervous system.

Th

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

nerve cells originate or receive impulses and impressions of various sorts

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

, which are conveyed by them to the muscles, blood-vessels, and so on, by e

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

ferent nerves, or received by them through afferent nerves coming from the

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

skin, organs of sense, joints, and other parts of the body. The autonomic n

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

Following aspects would a

ervous system is concerned mainly with the movement and other functions of

dd to the challenges in developing combination products:

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

he internal organs, secreting glands, and blood vessels, the activities of

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

which proceed independently of the will. In a sense, the autonomic nervous

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

ystem is the controller of all bodily functions.

Nervous diseases are some

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

of the most difficult diseases in so far as their diagnosis and treatment

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

Professional from academic institutions, pharmaceutical industries, health care indust

re concerned. The brain and the spinal cord are enclosed in the skull and t

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

he spine, beyond the reach of direct examination. Since the nerves everywhe

.

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

e are deeply buried in the tissues, the nature of nervous diseases must be

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

Companies that provide selfless information through particip

made out from the disturbances of the organs governed by the affected nerve

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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