E-Articles - Health and Fitness

There are some who might argue that depression is not an illness and causes little harm, except to the individual, but let me share a little story with you….

It was in 1985 when my husband and I w

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

ere stationed in Germany, where I suffered one of the worst cases of depression, ever! It was our first military overseas tour of duty, and my husband, a master sergeant in the Army National Guard

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

Examples of combination products may in

soon found himself overwhelmed with job and employee responsibilities.

While he worked for the Guard, I served as landlord in our military housing building-- helping other military families cope.

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

Several years came and went and then Desert Storm kicked in. Roy was requested by his colonel to work longer hours and weekends, to help support and maintain military operations in our area. Many

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

nights he had to stay over to assist in high-priority military maneuvers. This left me alone, lonely and with housing responsibilities.

Those long hours of separation from my husband caught up w

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

Combination pro

th me and my depression soon quickly turned into despair. I was worried about Roy and the horrible conditions surrounding Desert Storm. Like other military spouses, I wasn’t sure if I could handle

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

the pressure; there was just too much coming at us.

And, months later I suffered from a neck injury that caused me great pain, night and day. Pain pills did little to soothe the agony; so I search

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

ed my brain for an answer.

So, in that old and often noisy military building, I began to pray. Not being a church-going person but having some knowledge of the Bible, I began reading the Bible—fir

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

t a chapter a day, then followed by prayer. But soon, I found that it wasn’t enough. Days later, I began praying longer and reading such books of the Bible as Job—which helped me greatly dealing w

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

th the pain.

A burning desire grew inside of me. I wanted to know as much as possible about Christ-- his life, death, resurrection, promise of return and the giving of help to those in pain. I tho

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

ght if I could learn more about Him, maybe I could find an answer to the loneliness and physical pain I was going through. Maybe there were reasons for pain and suffering. Later, in the New Testame

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

Following aspects would a

nt, I did find some reasoning behind pain and suffering and it was a comfort.

As time went by, much of pain left me and as fall approached, I decided to take a leap of faith with my not- so- frien

dd to the challenges in developing combination products:

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

ly, military neighbors. For months they had shown little signs of neighborliness but what the heck, I thought. Why not take a chance? I had nothing to lose.

I got busy and made seven apple pies

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

bought and wrapped gifts for their children and delivered them to each family. I was surprised but happy with their kind response of my gifts. Afterwards, many who before had shown little neighb

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

orliness, thanked me and said how much they enjoyed the pies and gifts and wanted to know more about my husband and me. Finally, an open invitation to kindness and sharing!

While this was going o

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

, I continued to pray and read the Bible. I sought and found a piece of scripture I remembered from First Thessalonians 5:17 where Paul advocates: “Pray without ceasing…” I decided to put Paul’s a

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

Professional from academic institutions, pharmaceutical industries, health care indust

vice into action and for the first time in my life, I did “pray without ceasing.” The comfort and help I received from praying and Bible reading helped sustain me when I reached out to others who

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

were lonely and in pain. It wasn’t long before I realized I was no longer depressed. The depression no longer had a hold on me, for I was too busy praying and helping others.

The experience in G

.

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

rmany taught me valuable lessons on the power of praying and then acting on one’s faith. I learned that praying needs to be done everyday, be sincere, be directed to Jesus and be done “without cea

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

Companies that provide selfless information through particip

ing.” When you put those prayers into action with simple acts of faith, depression will have no choice but to flee!

References:

NT New Testament First Thessalonians 5:17:

Copyright Toni Star 200

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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