E-Articles - Health and Fitness

You probably already know what solar flares are. Those violent explosions in the Sun's atmosphere release huge bursts of energy that can match that of millions of hydrogen bombs released in unison. Solar flares heat the Sun’s gas to tem

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

peratures of many millions of kelvins. They speed up electrons, protons, and ions to near the speed of light, and produce tremendous electromagnetic radiation.

Sun flares affect geomagnetic fields, but what do they have to do with migr

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

Examples of combination products may in

ine headaches? Are there such things as solar flares migraine headaches?

Geomagnetic Activity

It has long been recognized that the earth’s magnetic field affects life on our planet. That magnetic field is not always the same, t

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

hough. It varies in intensity. Sometimes it is stronger. At other times, it is weaker. These variations are called geomagnetic activity or GMA. A great deal of GMA is influenced by the Sun, especially by solar flares.

Geomagnetic activ

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

ty is categorized by four levels:

1. quiet

2. unsettled

3. active

4. stormy

Geomagnetic Activity and Your Health

According to relatively recent studies, changes in geomagnetic activity can affect cardiovascular health. Ther

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

Combination pro

is reason to believe that GMA, specifically solar flares, can affect other areas of health as well.

Solar Flares and Migraine Headaches

One observation linking GMA and migraines found that more severe migraine headaches are se

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

en at hospitals on days with high levels of GMA. That means that when solar flares influence “active” or “stormy” levels of geomagnetic activity, doctors and nurses can prepare for patients with more serious migraine headaches to presen

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

themselves for treatment.

The relationship of solar flares and migraine headaches is strong. It has been shown that there is significant correlation between the two. An interesting study of this correlation is given in the following a

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

rticle: Kuritzky, A., Y. Zoldan, R. Hering, E. Stoupel (1987). "Geomagnetic Activity and the Severity of the Migraine Attack", Headache February 1987, pp 87-89. Stoupel, E., et al. (1989)

Migraine headaches can be triggered by a vari

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

ty of internal and external stimuli. For some migraineurs, it may be caffeine, chocolate, or red wine. For others, it might be stress or the let-down period that follows on the heels of stress. Many who suffer migraine headaches claim t

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

at weather is a major trigger for them. It might be a storm here on earth or solar flares, a storm on the sun. When they keep diaries, their migraine headaches enter the pages according to patterns of weather or solar flares.

Possib

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

Following aspects would a

le but Unproven

While researchers admit that there may well be a connection between solar flares and migraine headaches, the evidence is not yet clear. Of those who do keep migraine headache diaries,

When Dr. Patricia B. Prince an

dd to the challenges in developing combination products:

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

her colleagues of Boston’s Children’s Hospital set out to examine the relationship between headache and weather, they found that patients often believed weather was triggering their migraines headaches. However, when patients kept migr

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

aine headache diaries, that was proven in only about 20 percent of cases. Dr. Prince and her team believe that at least some migraineurs, when searching their memories for a likely trigger, may “selectively recall only the attacks that

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

upport their prior beliefs.”

This author read a personal account story on the Internet of an individual who was watching television one evening, having not the slightest hint of a migraine headache. The news anchor announced a forecast

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 intensified solar flares, and warned migraine headaches sufferers that solar flares and migraine headaches come hand in hand.

“Sure enough,” the TV viewer wrote. “Shortly after that, I got a terrible solar flares migraine headache.”

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

Professional from academic institutions, pharmaceutical industries, health care indust

Conclusion of the Matter

Solar flares have been proven to cause disturbances in the human body. There is no doubt of that. Whether or not solar flares cause migraine headaches is yet to be proven, but there is some evidence th

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

t they may be triggers for at least some individuals.

The solution for you may be to pay close attention to your own sensitivity to solar flares. Keep a solar flares migraine headaches journal, recording the onset and duration of every

.

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

headache. Do not keep track of solar flares that may be coming, as this may trigger self-fulfilling expectations of migraine headaches. After a headache is past, go back and check whether or not there were solar flares when it began. I

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

Companies that provide selfless information through particip

you cannot trust yourself not to look ahead, have someone objective check the information for you.

If you and your doctor pay close attention to your journal, it may help you prevent the onset of solar flare-related migraine headaches

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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