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The Internet as we know it may well have had the human nervous system as its inspiration.

The nervous system relies on a high-speed communications network to aler

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

t the brain to information that affects all areas of the body.

For instance the impulses sent from the nervous system to the brain travel at up to 250 miles per h

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

Examples of combination products may in

our. This is infinitely faster than the endocrine system that sends hormones through the bloodstream and may take an hour to get to their destination.

The nervous

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

system has the full attention of the brain and the brain responds. The responses can be the result of pain, enjoyment or other sensory data.

Electrically charged

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

neurons make up the communications landscape of the nervous system. When the nervous system kicks in electrical charges and chemical reactions are generated as inf

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

Combination pro

rmation is sent on a fast track to a brain that either calls for action or reaction to the supplied data stream.

The three primary elements of the nervous system

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

are the brain, the spinal chord and a complex nerve network reaching all areas of your body.

There are at least 24 different nerve centers in the body and all fiv

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

senses are reflected in the system controlled by neurons.

The function of the nervous system is to gear the body up for action or calm it to the point of relaxat

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

ion. The problem comes when our actions and our thought patterns tell our body’s nervous system to react in a way counter to what the body actually needs. For inst

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

nce we can insist on being worried and our body’s nervous system works overtime to help us keep tense and alert when the risk we imagine is not an identifiable thr

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

eat. This is often counterproductive to the actual needs of the body.

The journey of the nerve impulses has been described as “An electrical charge that travels d

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

Following aspects would a

own the cell membrane of a neuron’s dendrite and/or axon through the action of the Na-K pump. Ordinarily, the inside of a neuron’s cell membrane is negatively-char

dd to the challenges in developing combination products:

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

ed while the outside is positively-charged. When sodium and potassium ions change places, this reverses the inner and outer charges causing the nerve impulse to tr

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

avel down the membrane. A nerve impulse is “all-or-none:” it either goes or not, and there’s no halfway. However, a neuron needs a threshold stimulus, the minimum

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

evel of stimulus needed, to trigger the Na-K pump to go and the impulse to travel. A neuron cannot immediately fire again; it needs time for the sodium and potassi

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

um to return to their places and everything to return to normal. This time is called the refractory period.

“A junction between two nerve cells or a nerve and a m

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

Professional from academic institutions, pharmaceutical industries, health care indust

scle cell is called a synapse. In a synapse, various chemicals are used to transfer the impulse across the gap to the next cell. These are collectively known as ne

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

urotransmitters, and include such chemicals as dopamine (brain levels of which are low in Parkinson’s disease), serotonin, and acetylcholine (levels of which are l

.

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

w in myasthenia gravis).” [1]

The body's nervous system is an intricate method that relies on a logical series of events to trigger an appropriate body response.

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

Companies that provide selfless information through particip

Without this system we could not exist.

Perhaps the nervous system looks designed because it is designed.

[1] http://biology.clc.uc.edu/Courses/bio105/nervous.ht

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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