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Advice Pool - Not Just a Bout of the Blues
When I hit puberty, my body betrayed me. Before long I couldn't remember what it was like to feel healthy and normal. By the age of 14, I'd developed a long list of confusing and troubling physical problems. I was so exhausted I could hardly think or function. My body ached with joint and muscle pain. I had trouble concentrating and remembering little things. By 8 p.m
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
., I would crawl into bed totally worn out from doing next to nothing. Then I would spend the night fighting with insomnia.
It never occurred to anyone—not even my doctor—that I might be depressed.
Blood tests showed my immune system had dropped to dangerous levels. Further inspection unearthed tender lymph nodes. After several visits to the doctor, I was referred t
It never occurred to anyone—not even my doctor—that I might be depressed.
Blood tests showed my immune system had dropped to dangerous levels. Further inspection unearthed tender lymph nodes. After several visits to the doctor, I was referred t
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
o a specialist who promptly diagnosed me with chronic fatigue syndrome. Three years later I tried to kill myself.
My suicide attempt took everyone by surprise. No one had realized that while doctors did all they could to cure my physical symptoms, I was slowly being buried in darkness inside.
Although I felt comfortable talking about my physical ailments, I never re
My suicide attempt took everyone by surprise. No one had realized that while doctors did all they could to cure my physical symptoms, I was slowly being buried in darkness inside.
Although I felt comfortable talking about my physical ailments, I never re
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ealed what was happening inside of me. Life had lost its meaning long before the physical problems emerged. I felt like I had fallen into a deep black pit and couldn’t see even a speck of light at the top. I tried clawing my way out, only to wind up exhausted and hopeless. Then other days, I would be giddy with happiness for no reason. I assumed the bleakness of depre
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ssion and all the emotional ups and downs I experienced were things all adolescents went through.
My experience with depression was certainly different than traditional adolescent angst and it’s a real problem around the globe. According to a 2001 study by the World Health Organization, mental illness—such as depression, bipolar disorder and schizophrenia—ranks first
My experience with depression was certainly different than traditional adolescent angst and it’s a real problem around the globe. According to a 2001 study by the World Health Organization, mental illness—such as depression, bipolar disorder and schizophrenia—ranks first
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
in causing disability in the Western world compared to other diseases such as cancer and heart disease. In fact, mental illness accounts for 25 per cent of disability in the industrialized world.
Sadly, the prevalence of mental illnesses hasn’t made it easier to get treatment. My story of undiagnosed depression is all too common.
“Physicians can and do under-diagnos
Sadly, the prevalence of mental illnesses hasn’t made it easier to get treatment. My story of undiagnosed depression is all too common.
“Physicians can and do under-diagnos
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
e depression for many reasons, although most primary care doctors see a lot of depression in their practices,” says Dr. Marvin McDonald, a graduate professor in psychology at Trinity Western University in Langley.
Dr. Paul T.P. Wong, president of a non-profit organization called the International Network on Personal Meaning, agrees depression often goes misdiagnosed.
Dr. Paul T.P. Wong, president of a non-profit organization called the International Network on Personal Meaning, agrees depression often goes misdiagnosed.
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
He says this is because mental pain can sometimes show up as physical pain, either as a psychosomatic illness or as complaints of physical symptoms—especially in cultures where depression may be seen as a character defect. This makes it difficult for both the patient and the family doctor to recognize the real problem. “Most doctors are not very well trained in detec
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ing mental illness. They are trained to deal with physical illness or pain.”
McDonald notes patients and their families don’t always recognize depression, either. “It’s hard to sort out by common sense the difference between ‘being down’ and being clinically depressed,” McDonald explains. “Being depressed in response to stresses in life is normal in some way, so when
McDonald notes patients and their families don’t always recognize depression, either. “It’s hard to sort out by common sense the difference between ‘being down’ and being clinically depressed,” McDonald explains. “Being depressed in response to stresses in life is normal in some way, so when
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
do we slip into something else? This is a grey area for each of us—not just for professionals.”
Some level of personal depression is normal in the course of daily life. This type of depression can be triggered by loss, personal trauma or other negative life events. Death, divorce, or losing a job can all bring on about of the blues.
“(Reactive) depression is natura
Some level of personal depression is normal in the course of daily life. This type of depression can be triggered by loss, personal trauma or other negative life events. Death, divorce, or losing a job can all bring on about of the blues.
“(Reactive) depression is natura
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. It’s part of the normal emotional reactions to bad things happening to you,” Wong says.
A chemical imbalance causing clinical depression is something entirely different. This occurs when an individual lacks a substance in their brain. For them, the whole world can suddenly crumble. Then, with equal spontaneity, it lifts and life returns to normal.
“If our depressi
A chemical imbalance causing clinical depression is something entirely different. This occurs when an individual lacks a substance in their brain. For them, the whole world can suddenly crumble. Then, with equal spontaneity, it lifts and life returns to normal.
“If our depressi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
on or our ‘down’ time gets in the way of everyday life, if it keeps us from doing our work or gets in the way of everyday relationships, then we have crossed the line from everyday struggles to a mental health problem,” McDonald says.
In my case, the depression was from a chemical imbalance, which must have developed during puberty. Today, almost 10 years later, I st
In my case, the depression was from a chemical imbalance, which must have developed during puberty. Today, almost 10 years later, I st
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ill take medication to keep the black dog of depression at bay. Although I have developed excellent coping skills over the years, I am often left exhausted from the effort.
I honestly couldn’t imagine fighting this without medication. Just one little pill each day enables me to enjoy life as an outgoing and happy person who connects with others easily. Without this h
I honestly couldn’t imagine fighting this without medication. Just one little pill each day enables me to enjoy life as an outgoing and happy person who connects with others easily. Without this h
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
lpful aid, I turn into a surly recluse and become unwilling to leave my house, talk to other people or have fun doing activities I regularly enjoy.
I am astounded by how many depressed individuals refuse to take medication because they worry about what others will think. But even without telling anyone, the list of people privy to your medical information is pretty l
I am astounded by how many depressed individuals refuse to take medication because they worry about what others will think. But even without telling anyone, the list of people privy to your medical information is pretty l
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ong. Your pharmacist, your healthcare provider, and even the human resources or the accounting department at your office all know what type of medicine you’re taking and why. Life insurance and other insurance providers also require this information. I remember breaking out in a cold sweat when my insurance provider asked me about my prescriptions for my life insuranc
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
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
application. I was so ashamed.
Perhaps one of the most difficult parts of struggling with a chemical imbalance is dealing with the stigma still attached to depression. When friends learn that I take pills for depression, there’s a brief instant between this discovery and their ability to mask their facial expression. I see the shock, horror and pity appearing in the
Perhaps one of the most difficult parts of struggling with a chemical imbalance is dealing with the stigma still attached to depression. When friends learn that I take pills for depression, there’s a brief instant between this discovery and their ability to mask their facial expression. I see the shock, horror and pity appearing in the
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ir faces and feel completely and utterly ashamed of my weakness.
McDonald explains this is a common stigma. “Depression is connected with weakness. The paradox of trying to help people reduce blame for mental illness by emphasizing genetic sources is that, instead of blaming people for being weak in willpower, now people are perceived as genetically flawed and thus t
McDonald explains this is a common stigma. “Depression is connected with weakness. The paradox of trying to help people reduce blame for mental illness by emphasizing genetic sources is that, instead of blaming people for being weak in willpower, now people are perceived as genetically flawed and thus t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o be pitied, which is not better than being blamed,” he says.
Fortunately, education is helping to dispel some myths surrounding depression. Wong encourages depressed individuals not to be ashamed. He says some very successful people suffer from depression, proving people can function very well while coping with this disease.
If you think you may be suffering from d
Fortunately, education is helping to dispel some myths surrounding depression. Wong encourages depressed individuals not to be ashamed. He says some very successful people suffer from depression, proving people can function very well while coping with this disease.
If you think you may be suffering from d
.
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
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
pression, see your family doctor and ask for a referral to a therapist. In less serious cases a combination of medication and talk therapy does help.
If you know someone who is suffering, don’t be dismissive or pretend it’s not happening. Reserve passing judgement and encourage them to seek help. It’s my hope that society will begin treating depression and other ment
If you know someone who is suffering, don’t be dismissive or pretend it’s not happening. Reserve passing judgement and encourage them to seek help. It’s my hope that society will begin treating depression and other ment
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
al illnesses as they do physical illnesses.
If you break your leg, no one expects you to sit around and pretend it’s not broken. People suffering with cancer, AIDS and chronic illnesses are all free to seek treatment without judgement and yet many with depression and other mental illnesses hide in the dark, afraid to ask about a cure. Isn’t it time for this to change
If you break your leg, no one expects you to sit around and pretend it’s not broken. People suffering with cancer, AIDS and chronic illnesses are all free to seek treatment without judgement and yet many with depression and other mental illnesses hide in the dark, afraid to ask about a cure. Isn’t it time for this to change
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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