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Delicious - Fate, Destiny, Kismet
Nowhere you can be that isn't where you're meant to be John Lennon, Paul McCartney
Fate, Destiny, Kismet... All relate the idea that what happens to us in th
Fate, Destiny, Kismet... All relate the idea that what happens to us in th
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
is lifetime is fixed, predetermined, inescapable.
Depending on your point of view it could be horrifying to think we are mere robots, unable to deviate one iota fro
Depending on your point of view it could be horrifying to think we are mere robots, unable to deviate one iota fro
; 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
m our fixed pathway. Indeed, if we have no Will, we - as individuals - do not really exist.
Or it might be comforting. For if all that happens would have happened r
Or it might be comforting. For if all that happens would have happened r
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
egardless we are relieved of blame, responsibility and guilt.
Modern society certainly doesn't subscribe to this view. The legal system assumes responsibility for a
Modern society certainly doesn't subscribe to this view. The legal system assumes responsibility for a
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tion, and hence freedom of the Will, by punishing those guilty of sin (ie crime). And capitalism rewards enterprise.
And what of our own experience. Surely there ar
And what of our own experience. Surely there ar
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e numerous occasions each day when we are called upon to make decisions. The problem is that as mortals time appears as ever-flowing and unidirectional. So once we'v
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 made a decision, and acted upon it, it seems that things couldn't possibly have turned out any other way.
But even if we are captains of our own ships we still ha
But even if we are captains of our own ships we still ha
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
e no control over the forces of nature or the other ships we share the oceans with. We have free Will, but it's a limited freedom. We can make choices, but those cho
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ices operate against a backdrop of circumstance over which we are powerless. And it is these externalities which we call destiny or fate.
What of providence? This i
What of providence? This i
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
s the idea that God, or Spirit, will somehow take care of our earthly needs. It is surprising how many often in troubled times the solution unexpectedly appears. Thi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is evidence that we are part of some greater, mostly unperceived, reality. But we should not use providence as an excuse to abdicate responsibility otherwise we obv
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
iate the need for our earthly existence. We must still use our Will to the best of our ability and sometimes fate will lend a helping hand.
What of luck? The idea t
What of luck? The idea t
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
hat some experience better fortune than others. The concept of luck is born of comparison with others. It is true that we are all born into different conditions, wit
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
h different talents and other qualities. So too will our experiences differ vastly in nature and desirability. No two lives are alike. If they were there would be no
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
point in them being lived twice. We all tread a different path, and - believe it or not - we all chose the lessons we would learn along ours. We should not be enviou
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
s of the fortunes of others, instead we should focus on making the best of our own particular path in the knowledge that we tread it for good reason.
The paradox of
The paradox of
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
significance begins with the recognition of the utter insignificance of a single man in comparison with the totality of the universe. And yet every act of Will some
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ow alters what would otherwise have been, ultimately and forever. Like the ripples spreading out from a stone tossed into the sea. Suppose in our daily affairs we me
.
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
et someone on their way to a job interview. A simple "good morning" or friendly glance might be enough to inspire that person to success. And in the course of their
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
work they may go on to touch many other souls. And all because of one simple, costless action. A crude example, but without much imagination we can produce many more
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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