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E-Articles - A Stroke of Genius
Let us take a look inside a functioning alcoholics lifestyle. One would say at first, "Oh yuk! What a disgrace. What a burden to society." That is the outlook of the average citizen of the United States, and probably the world.
But let's delve in a little deeper and look at one in particular. His name is Richard. He grew up as a normal person, had the schooling and the life of what we would call normal. But in his early teens he found alc
But let's delve in a little deeper and look at one in particular. His name is Richard. He grew up as a normal person, had the schooling and the life of what we would call normal. But in his early teens he found alc
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
ohol. He found that it made his world a whole lot cheerier, a whole lot easier to deal with that awful feeling he'd always had in the pit of his stomach.
So whenever he got the chance, he drank. It made his life so much better. His perspective on his reality changed for the better when he did this. Then he found marijuana. This was in the '70's, when it was easy to get. Wow, he had found a whole new way of customizing his reality to fit h
So whenever he got the chance, he drank. It made his life so much better. His perspective on his reality changed for the better when he did this. Then he found marijuana. This was in the '70's, when it was easy to get. Wow, he had found a whole new way of customizing his reality to fit h
; 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
im. Plus, you didn't have to hide the alcohol on your breath, and you weren't hung over the next morning. Perfect.
What he didn't realize was that he suffered from depression. He thought that sick dreadful feeling he always had was just the way everybody felt. He hadn't a clue it was depression. So he continues on in his life making that feeling go away by smoking pot. Then he finds love. He's 17 and had never been in love before.
Richar
What he didn't realize was that he suffered from depression. He thought that sick dreadful feeling he always had was just the way everybody felt. He hadn't a clue it was depression. So he continues on in his life making that feeling go away by smoking pot. Then he finds love. He's 17 and had never been in love before.
Richar
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d gets married at the tender age of 18, and as most 18 year olds are, thought he knew everything and had complete control of the world. But his new wife doesn't like him drinking or smoking pot, so now begins his life of deception. For ten years he secretly gets high at work. Smoking pot had become his only only way to survive the God-awful reality he had to deal with if he wasn't high. But it was hard and tricky to do.
In the meantime, t
In the meantime, t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he couple gave birth to two boys and had a nice little family going for them. That's when his wife gives in to them partying by drinking beer on the weekends with their friends. Thus began Richards real taste of what alcoholism was really like. It never became prevalent before because he was smoking that funny stuff. But now, with the okay from his wife, alcohol took over.
Slowly but surely it became his mainstay. He'd gotten a job at the
Slowly but surely it became his mainstay. He'd gotten a job at the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Post Office working the night shift. And he had to work the weekend, so he couldn't party with his wife and friends. But oh, he'd so gotten used to the way it made him feel. He felt normal, he thought, like everyone else. So he began drinking at work. On the way to work he would stop at the liquor store, buy a pint of vodka, and chug half of it down before his shift began.
That's when his life began to fall apart. Work noticed his perform
That's when his life began to fall apart. Work noticed his perform
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
ance and he was abusing his sick leave also. Thus commenced rehab #1 for him. But, as true alcoholics are, denial of the problem won out. He didn't believe had a problem. He didn't drink to get drunk, he did it to make his world fit. What was wrong with that. Then he got his first DUI. Then all the problems began to escalate and his wife could handle it no more. So a divorce after 12 years took care of her problem. But what about his?
He
He
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
started to realize he "did" have a problem with alcohol. He went into rehab again, as the first one didn't take. He'd lost his job at the Post Office and decided to try his hand at cooking while he was in rehab. They let you leave the rehab house to go to work, and breathalyzed you when you came back. Richard found he could do this. At the place that he cooked at he met wife #2.
Pretty soon he moved in with her and, to his knowledge, she
Pretty soon he moved in with her and, to his knowledge, she
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
didn't know he was an alcoholic. But heck, Richard still didn't think he was an alcoholic. She had two boys that needed a father, so he stepped right in. They got married. But Richard found out his new wife liked to smoke pot. So much the better for him. Now he didn't have to drink to get rid of that sick feeling. He could smoke it away. Which he did for nine more years.
Then one day while they were getting high she says to him, "I want a
Then one day while they were getting high she says to him, "I want a
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
divorce". Richard asks her why, and she says, "I'm just not happy". Being the person Richard is, he can't see her being married to him if she's not happy, so he says "okay" and packs his stuff and moves out to an apartment.
For the nine years they were married, Richard had gotten back into being a machinist and had a solid job at a place he had worked at during those nine years of his second time around. Now this is where our funtioning
For the nine years they were married, Richard had gotten back into being a machinist and had a solid job at a place he had worked at during those nine years of his second time around. Now this is where our funtioning
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lcoholics life really takes a twist. He had good friends at work that he really cared about. One of them must have felt sorry for him going through a divorce, so he invites him into his section of the shop they worked at and turns him on to a hit of crack cocaine.
All at once it dawns on Richard as to why his coworkers had been missing so much work lately, and a few of them had even quit. They were hooked on crack. After his whole life of
All at once it dawns on Richard as to why his coworkers had been missing so much work lately, and a few of them had even quit. They were hooked on crack. After his whole life of
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
addiction, Richard knew this was no way for his friends to go. He goes home that evening and contacts the DEA and the Sheriffs Narcotics department.
He begins a quest of what he thought was going to stop his friends from going down the same road he had already been on. He gets involved to the point that he quits his job and even moves a crack dealer into his place to enable him to collect much information on the main source of where this
He begins a quest of what he thought was going to stop his friends from going down the same road he had already been on. He gets involved to the point that he quits his job and even moves a crack dealer into his place to enable him to collect much information on the main source of where this
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
devastating drug is coming from. He becomes addicted to this drug so he can "look" like one of them.
To his chagrin, both of the agencies use him to make busts, but they do it at his place, which ruins his credability with the dealers of that drug world. He has been used and hung out to dry and still addicted to this powerful drug. He was told by the narcotics department that they would help him with rehab, but after they made the bust,
To his chagrin, both of the agencies use him to make busts, but they do it at his place, which ruins his credability with the dealers of that drug world. He has been used and hung out to dry and still addicted to this powerful drug. He was told by the narcotics department that they would help him with rehab, but after they made the bust,
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
they just dropped him.
So Richard is at a loss now as to what to do. He finds himself doing unsavory things to get his drug, so he comes up with a plan to get himself off of the streets of which he is doing these bad deeds. The details are just too enormous to go into here, but I will tell you what he did do that was to his demise. He came up with a plan of committing a crime so that he would be in jail and off of the streets. He commits
So Richard is at a loss now as to what to do. He finds himself doing unsavory things to get his drug, so he comes up with a plan to get himself off of the streets of which he is doing these bad deeds. The details are just too enormous to go into here, but I will tell you what he did do that was to his demise. He came up with a plan of committing a crime so that he would be in jail and off of the streets. He commits
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
the crime of theft by deception. That is taking something that is not yours and pawning it.
He did this several times to make sure it was a big enough crime for them to take him off the streets. You see, he had already tried one time by turning himself in for a warrant they had out for him, and they just released him on his own recognisance. He wanted off the streets. So he did this theft by deception thing quiet a few times, and then tur
He did this several times to make sure it was a big enough crime for them to take him off the streets. You see, he had already tried one time by turning himself in for a warrant they had out for him, and they just released him on his own recognisance. He wanted off the streets. So he did this theft by deception thing quiet a few times, and then tur
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
ed himself in. Needless to say, he was so successful that they put him in prison.
The point I'm tring to make here is, who cares? Although Richard didn't just wake up one day and decide he wanted to be an alcoholic for the rest of his life, that alcoholsm is a disease, who cares? That all of these diseased peole are costing society money? That they're a strain on us? But hey! What if it was YOU!!! Oh, thats okay. You're just another perso
The point I'm tring to make here is, who cares? Although Richard didn't just wake up one day and decide he wanted to be an alcoholic for the rest of his life, that alcoholsm is a disease, who cares? That all of these diseased peole are costing society money? That they're a strain on us? But hey! What if it was YOU!!! Oh, thats okay. You're just another perso
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
n. Who cares? We have lots of them.
But what if it was you. Wouldn't you want some help? Some understanding? You would? Where would you find that in todays world? So let us finish the story of our, yuk, alcoholic. So after Richard gets out of prison and his life really sucks now, forget the fact that he was trying to help his friends and others, he returns to drinking. He can't smoke pot now, which he would really rather do, because he's
But what if it was you. Wouldn't you want some help? Some understanding? You would? Where would you find that in todays world? So let us finish the story of our, yuk, alcoholic. So after Richard gets out of prison and his life really sucks now, forget the fact that he was trying to help his friends and others, he returns to drinking. He can't smoke pot now, which he would really rather do, because he's
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
on parole and has to do UA's for his parole officer. He drinks because it doesn't show up on them.
He's right back where he started with the drinking. His life is miserable. He wished he were dead. He had even tried suicide a few times, but someone kept intervening and making his attemps unsuccessful. But instead, something miraculous happens to him. He has a stroke. His parole officer comes and see's him and takes him off their papers be
He's right back where he started with the drinking. His life is miserable. He wished he were dead. He had even tried suicide a few times, but someone kept intervening and making his attemps unsuccessful. But instead, something miraculous happens to him. He has a stroke. His parole officer comes and see's him and takes him off their papers be
.
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
ing as he's not a menace to society anymore. Of coarse he never was. And then one night in the stroke ward of the hospital of which they don't let visitors in at night, he has a visitor. An Angel comes to him out of nowhere. She heals him of not only his stroke, but his alcoholism as well. It really was a stroke of genius. That genius is "The All".
So now as we end our story, we find out that Richard has written a book about his amazing e
So now as we end our story, we find out that Richard has written a book about his amazing e
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
xperiences. He calls it "My Swim With The Sharks" for that is what he did, only the sharks are us, people. Then he has gone on to write another book he calls "The Evolving Belief". Richard went on to do much research into quantum physics, the universe, our reality, and the nature of God, whom he refers to as "THE ALLl", in which he hopes to convey a message. One that I believe will open everybodies eye's as to why we're here and who we are
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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