Advice Pool - Health and Fitness

Many of us know that there is a strong connection between what we think and how we feel, but just how can something as abstract as a thought have such a powerful affect on our bodies? Perhaps an answer can be found by looking a

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 mind and body as part of a complex information system.

First of all from a scientific perspective a thought consists of the transmission of electrochemical impulses throughout a network of brain cells called neurons. The

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

Examples of combination products may in

neurons talk to each other by making connections with other neurons and secreting little packets of chemicals called neurotransmitters. The brain is so complex that it has been said to contain nearly ten billion neurons. Each

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

of these ten billion neurons can connect with up to ten thousand other neurons. The possible connections actually exceed the number of known particles in the universe!

Each packet of neurotransmitter can be thought of as a tin

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

y set of instructions telling another neuron what to do. The instructions can tell the next neuron to fire an impulse to another neuron or to hold the impulse back by inhibiting it. The billions of instructions going on in our

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

Combination pro

brains represent a vast information network.

So how does the information network of the brain communicate with the body? Or to put it another way, where does the mind end and the body begin? This is a tough question to answer

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

because depending on how you look at it there is no definitive dividing line between mind and body. Both are intimately interconnected. The body is also a complex information system.

The body has thousands of feedback systems

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

that rely on a constant flow of information and these systems are connected to the nervous system. For example the nervous system constantly monitors blood pressure. The nervous system senses an increase or decrease in blood pr

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

essure and responds by sending information to the heart and blood vessels to stabilize the pressure.

This complex connection between mind and body not only keeps things working properly but can also have negative effects on yo

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

ur health. For example, in times of stress a part of the nervous system called the sympathetic nervous system takes over and secretes neurotransmitters such as adrenaline. Adrenaline causes your heart rate and blood pressure to

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

increase as well as your digestion to shut down. The sympathetic nervous system is so interconnected with the organs in your body that the effects of stress can be profound. For example, prolonged periods of stress can affect

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

Following aspects would a

the digestive system so much that an ulcer can develop.

Another pathway between mind and body is called the hypothalamic pituitary adrenal axis. The hypothalamus is located deep in the brain and is affected by thoughts and emo

dd to the challenges in developing combination products:

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

tions. It connects with the pituitary gland that secretes a number of hormones some that target the adrenal gland. One important hormone secreted by the adrenal gland in times of stress is cortisol. Cortisol increases blood sug

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

ar levels and blood pressure. High levels of cortisol can put stress on other organs and contribute to disease.

The important point is that the stress coming from the nervous system originates as a series of thoughts in the br

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

ain. These thoughts are physical things and can elicit a physical effect on the body. The thoughts come from our perceptions. Stress is something that is perceived. You can choose to perceive a certain situation as stressful or

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

not.

This mind-body connection can be used to heal. The science of psychoneuroimmunology studies the effects of the mind on the body. Mind-body healing has been shown to be effective in a host of illnesses and diseases such a

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

Professional from academic institutions, pharmaceutical industries, health care indust

s high blood pressure, stress, increased immunity, pain control, and many others.

One effective mind-body technique that anyone can do is called guided imagery. In guided imagery you are guided through a process of relaxation

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

followed by creating an image of your pain or disease. The image is then replaced by an image of health or healing. The technique is performed frequently, often daily and lasts anywhere from ten minutes to an hour. Some people

.

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

become very adept at imagery after practicing the technique and can experience benefits from just ten minutes a day.

Guided imagery is a simple yet effective tool in a healing regimen. I have used this technique frequently and

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

Companies that provide selfless information through particip

found it to be very beneficial in helping with a variety of health problems. Mind-body healing is one way to help support your body’s many information systems and help you to heal by maintaining a positive flow of information.

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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