Suggest - Self Improvement

Once upon a time, I was a vibrant, youthful teenager...

My First Encounter

During my first pregnancy, I had contracted chicken pox from my young nephews and niece. Though it made for an irritable time in my initial trimester, I hadn't given it much aforethought. In the last part of my pregnancy, I noticed some weakness in my le

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

gs and arms, but naturally assumed it was part of the gestational effects.

It was after I gave birth, that I began having more frequent physical difficulties, but again, attributed these nuisances to normal post-partum effects. As time progressed, I began losing balance & coordination; and even dropped everyday household items such as glasses

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

Examples of combination products may in

, keys, and other things as well. I had finally had enough when my rib cage began to feel broken and I couldn't stand the pain any longer. Over a decade later, and after numerous doctor visits, MRIs and multiple lab tests; I was finally diagnosed with Fibromyalgia.

What is Fibromyalgia? Fibromyalgia is a chronic pain illness that can cause mu

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

sculoskeletal pain in various areas of the body, is characterized by fatigue, and is often associated with Restless Leg Syndrome, Migraine and rheumatism - to name a few. Additionally, attacks of fibromyalgia seem to spontaneously come and go.

At first, I was treated with multiple 'pain aids' that did help with the pain, but made me even more

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

tired than I was before I took the medicines. Eventually, I went off the medications and focused on my work and simply 'ignored' the illness. I figured if I had to live with it, I might as well accept it.

What I Didn't Know

What I didn't realize was that Fibromyalgia can weaken a person so much that sometimes, individuals can be more

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

Combination pro

quickly injured or more prone to other conditions than those without Fibromyalgia. That's when I experienced my first real encounter with its lethal effects. While at work, I wasn't doing anything too terribly physical. However, it was the day in and day out repititions of physical labor that not only added to my condition but wrecked further

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

havoc on me as well - and left me susceptible to injury.

On the Job Injury

There I was, performing my normal work activities when, 'Ouch!' and 'Oh my God!' entered my mouth. The pain was excruciating. Numbing and impairing. With a simple maneuver, I was incapacitated. Pain and tingling numbness ran down my right side. It was unbearab

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

le. Not only that, I could barely make it to the office because I had to drag my right leg to get to where I needed to be.

When I got to the hospital, I was told that "...you sprained your back..." That was it. No MRIs, just a quick once-over to tell me that all my pain, my lack of feeling - according to workers compensation' doctors - was me

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

rely a 'sprained back.'

I knew I had fibromyalgia, but it had NEVER acted in this sense. Not because I was 'weak,' but because my right side had gone totally numb. It was frustrating to say the least. Nearly 9 months after my injury, and even working on light-duty while taking heavy pain killers, doctors FINALLY found that my right shoulder h

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

ad been subluxated (dislocated) and scheduled me for surgery. After the surgery, I went through months of agonizing physical therapy to get my right arm back into its proper range of motion. But the numbness, the back pain and the lack of feeling in my legs still came and went without any signs of remorse.

Shocking Discovery

By the ti

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

me I had went through my rehabilitation, my employer 'let me go' because I was obviously unable to work. I attempted to go back to work as an office manager for a wonderful & understanding employer, (I figured it was light work.) and performed fairly well for a few months. Suddenly, I was in a hospital emergency room - this time, I came out in

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

Following aspects would a

a wheelchair. Not only did MRI tests confirm I had a herniated disc at the C-3/4, but I also had a spinal lesion (myelopathy) at the C-1/2. Strange that workers compensation doctors coudn't find it, but numerous MRI tests this time, confirmed it.

After seeing a few, reputable Neurologists, I was additionally diagnosed with Transverse Myeliti

dd to the challenges in developing combination products:

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

s (TM) and a 'bulging disc' (herniated disc). This explained why I had been encountering all these unrelated physical problems.

Giving Up

I guess when I first sat in my wheelchair, I instinctively gave in to my physical condition. Why bother living anymore, I thought. I couldn't function properly and felt like a complete invalid. How

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

was I going to make my household payments? How was I going to care for my two, then elementary schoolers? How was I even going to live? While all these thoughts ran through my mind, I was becoming an emotional wreck.

Because of my health, I was taking so many medicines that I couldn't tell if I was coming or going. I would take one medicine f

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

or this, one for that, one to counteract the effects of another, and another to counteract the effects of a different one...and so on. And thanks to all of these wonderful conventional medicines, I returned to the hospital because one of them nearly killed me. It was then that I knew I had to find a different way.

Starting Over

Going

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

against medical advisement, I literally stopped all of my prescribed medicines at once. I became acquainted with the International Disability Coalition and got into band, strengthening excercises and virtually re-taught myself how to walk - without the help of any medical professional. I also incorporated a 'mind-over-matter' attitude that I b

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

Professional from academic institutions, pharmaceutical industries, health care indust

elieve, enabled me to step out of the wheelchair and back into life.

It's been about 3 years now, and I still live daily with back, neck, shoulder and sciatic nerve pain. I sporadically suffer relapses where I can't walk, or I can't move my arms or hands. BUT, I am no longer a walking or wheelchair-bound zombie. I swim and practice water exer

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

cises when the weather is warm to build muscle strength. And there are still times when my pain gets the better of me and I still go through emotional ups and downs. And like most conditions, they flare up more often with cold weather, emotional and physical stress, and lack of rest. BUT I am alive today, I am a survivor, and though I may have

.

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

fibromyalgia, Transverse Myelitis, migraine, disc herniation, and restless leg syndrome - these disorders do NOT have me.

In Closing

Living with my chronic disorders and illness has taught me to be more patient...more loving...more giving. I now share my home with not only my human family, but have adopted several rescue dogs - who I

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

Companies that provide selfless information through particip

also compliment for adding so much love and compassion to my emotional wellbeing. And so long as there is a purpose on this earth for me to exist, I will attempt to make the most of it. Every hour. Every day.

Living with Chronic Illness & Disorders: Are You a Survivor?
Copyright 5/2005 - All Rights Reserved
by C. Bailey-Lloyd

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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You are a marketing professional. If you were to answer few questions, will you be able to? Let me ask you. What is the birthday of your top ten buyers? What is the date of their wedding anniversary? How many children do they have and what are their birthdays.

We are watching as more and more jobs flow off our shores, where products can be made cheaply. There are obviously issues with the differences in the cost of labor throughout the world, which are so great that it is an impossible chasm to cross, even using sophisticate robotic manufacturing processes.

In order to understand why it is essential to lower your cholesterol, it is required that you first have a handle on what cholesterol is.

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