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Top Adding - The Mad Shephard
Everyday he guides his sheep out into the pastures
Carefully choosing the greenest areas
Const
Carefully choosing the greenest areas
Const
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
antly looking out for streams and springs
He treats his sheep tenderly, knows each by name
The
He treats his sheep tenderly, knows each by name
The
; 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
sheep in turn know and respond to his voice
But lo the times and seasons start changing
A rava
But lo the times and seasons start changing
A rava
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ging drought hits the land
Soon the green fields are nothing but bare wastelands
He braves the
Soon the green fields are nothing but bare wastelands
He braves the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
drought, moving his herd further and further
Hoping for greener pastures
He always manages to
Hoping for greener pastures
He always manages to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
get enough to keep his sheep alive
He fights off the wild beasts of the field himself
Always m
He fights off the wild beasts of the field himself
Always m
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
anging to protect his flock
But one day he wakes up angry
He cant take it anymore, he says
But one day he wakes up angry
He cant take it anymore, he says
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 picks up an uzi submachine gun
Runs to the sheep pen
Hearing his footsteps, the sheep blea
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
, eagerly anticipating another outing
He looks at his sheep one last time, no mercy in his eye, bli
He looks at his sheep one last time, no mercy in his eye, bli
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
nd with unimaginable anger
He wipes all of them out
All he had lived for, all he had
GON
He wipes all of them out
All he had lived for, all he had
GON
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
in a jiffy, all in one fit of anger
A few days later, as he sits, lonely and dejected
Clouds
A few days later, as he sits, lonely and dejected
Clouds
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
orm from the east, the first signs of rain
The drought is over, if only he had waited a few more da
The drought is over, if only he had waited a few more da
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
ys
If only he had persevered to the end.
Perseverance and patience in the face of suffering is
If only he had persevered to the end.
Perseverance and patience in the face of suffering is
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
called for in the bible. James talks about double minded people saying that these shall receive nothing
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
rom God (James 1:7), the shepherd in this case did not have a firm stand in regard to his flock, he acce
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
pted wrong thinking, that what he was suffering for was not worthwhile. This made him loose his mind, he
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
did not persevere till the end, he might as well have killed his flock when the first trial came his way
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
"How does this applicable", would be the question you should be asking yourself. After investing so muc
.
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
h time in his flock,to the point of the sheep knowing his voice, at times putting his life on the line f
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
r them, he just wakes up and massacres what he lived for. What a shame, non of us should end up this way
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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