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ArticlePedia - I Think I'll Just Go Fishin'
I said something last week I haven't said in years. Where it came from, I really don't know. It's funny, you're tooling along minding your own business for weeks, maybe months at a time, and then something you haven't thought about for years pops into
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
your noodle.
I don't remember what brought it on, but I blurted out, "I think I'll just quit everything and go fishin'."
Where the phrase came from is a mystery because I can't remember the last time I went fishing. It's tragic when a person gets so
I don't remember what brought it on, but I blurted out, "I think I'll just quit everything and go fishin'."
Where the phrase came from is a mystery because I can't remember the last time I went fishing. It's tragic when a person gets so
; 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
busy he forgets about the truly essential things of life. There is nothing, in my mind (at least that's my wife's opinion) more essential in life than fishing.
In the heart of my tackle box, I am a true-blue fisherman, especially if it's a cold mornin
In the heart of my tackle box, I am a true-blue fisherman, especially if it's a cold mornin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
g and I am waste deep in frigid water.
Two types of people indulge in this business of fishing.
Some take up fishing as a hobby to get away from the rat race of life. And there is nothing like fishing to do just that.
When at work they think of fish
Two types of people indulge in this business of fishing.
Some take up fishing as a hobby to get away from the rat race of life. And there is nothing like fishing to do just that.
When at work they think of fish
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing, and when fishing, they think of work. These are not real fishermen, they just play one on their holidays and no self-respecting sporting goods store should be allowed selling them any fishing tackle.
Then there are those who are born fishermen. I
Then there are those who are born fishermen. I
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
's not something they chose, just like nobody chooses the color of their eyes, the color of their skin or what year they were born n although some fudge here a little. My motto: a little fudge is good for your soul. These are just born fishermen and th
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
ere is nothing they can do about it. Whether it's the sovereignty of God or predestination I'm not sure, I just know it happens.
Sometimes the best thing a person can do is drop everything and just go fishing. If more people did this, it might cut dow
Sometimes the best thing a person can do is drop everything and just go fishing. If more people did this, it might cut dow
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
n on the war and violence in our world.
People need to know several things about "going fishin'" and fishermen in general. Fishermen are an abused minority and grossly misunderstood by the general population. As far as I know there is no voice standin
People need to know several things about "going fishin'" and fishermen in general. Fishermen are an abused minority and grossly misunderstood by the general population. As far as I know there is no voice standin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
g up for these poor souls. Maybe its because voices can't stand and then there are some voices I can't stand.
In the first place, fishing has everything to do with the equipment n and not just any equipment will do. In some regards, it takes a lifetim
In the first place, fishing has everything to do with the equipment n and not just any equipment will do. In some regards, it takes a lifetim
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
e to acquire the proper equipment to go fishing. This is where the true-blue fishermen are greatly misunderstood.
No true-blue fisherman would ever think of going fishing without his lucky hat. Going fishing without your lucky hat is like going to a r
No true-blue fisherman would ever think of going fishing without his lucky hat. Going fishing without your lucky hat is like going to a r
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
staurant without your appetite; what's the point?
This essential part of his fishing equipment is lucky because it hosts several lucky fishing lures and flies, all meticulously arranged around the hat, representing some story associated with his fishi
This essential part of his fishing equipment is lucky because it hosts several lucky fishing lures and flies, all meticulously arranged around the hat, representing some story associated with his fishi
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
ng adventures. Some stories may be true, but not all, and in time the owner of the hat can't remember which are true and which are not.
Another misnomer about going fishing has to do with catching fish. Let me state right here that catching fish has a
Another misnomer about going fishing has to do with catching fish. Let me state right here that catching fish has a
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
bsolutely nothing to do with going fishing. In fact, no true fisherman would ever go fishing with the idea of catching any fish. For the most part, it is the furthest thing from his mind.
When a fisherman goes fishing and catches a fish, he has nothin
When a fisherman goes fishing and catches a fish, he has nothin
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
g to talk about. And whatever else a fisherman loves doing, it is talking.
If, for example, a fisherman goes fishing all day and catches 20 fish, there is only one subject he will talk about when he gets back. No, it is not the 20 fish he caught. Afte
If, for example, a fisherman goes fishing all day and catches 20 fish, there is only one subject he will talk about when he gets back. No, it is not the 20 fish he caught. Afte
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
r all, they are right in front of you; what else is there to say about it?
If the biggest fish, for instance, is 13 inches he cannot exaggerate and say it is 18 inches. The presence of the fish precludes stretching the truth, not that a fisherman woul
If the biggest fish, for instance, is 13 inches he cannot exaggerate and say it is 18 inches. The presence of the fish precludes stretching the truth, not that a fisherman woul
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
lie — he just improves on the truth as he sees it.
Often, when a fisherman does catch a fish he throws it back under the pretense of it not being big enough.
The singular subject of a fisherman's talk when returning from fishing is simply, "the one
Often, when a fisherman does catch a fish he throws it back under the pretense of it not being big enough.
The singular subject of a fisherman's talk when returning from fishing is simply, "the one
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
that got away." No matter how big his biggest catch of the day is, the one that got away out-scales them all.
He may never have seen that fish, but it has nothing to do with his recitation of the one that got away. Something about that fish, whether r
He may never have seen that fish, but it has nothing to do with his recitation of the one that got away. Something about that fish, whether r
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
eal or imaginary, stirs the imagination of a true-blue fisherman. And, whether he saw that fish or not, he can talk for weeks, months and even years about that one.
A real fish in time spoils and eventually stinks; however, the one that got away alway
A real fish in time spoils and eventually stinks; however, the one that got away alway
.
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
s improves with age.
I find myself in good company in this area. No less a person than the apostle Peter did the same thing. He was frustrated and didn't know what to do so he did the thing that came natural to him.
"Simon Peter saith unto them, I go
I find myself in good company in this area. No less a person than the apostle Peter did the same thing. He was frustrated and didn't know what to do so he did the thing that came natural to him.
"Simon Peter saith unto them, I go
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
fishing. They say unto him, We also go with thee. They went forth, and entered into a ship immediately; and that night they caught nothing." (John 21:3 KJV.)
I did not go fishing last week but just the thought of it was an amazing elixir to my spirit
I did not go fishing last week but just the thought of it was an amazing elixir to my spirit
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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