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E-Articles - Opening the Buds
Watching the trees begin to blossom in the springtime is an awesome and sanctifying experience. Watching people blossom is also an awesome and sanctifying expe
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
rience. People are very much like trees. We often use tree metaphors when we talk about an individual -- such as "she's a budding dancer" or "do not be a sap
; 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
or "the apple does not fall far from the tree." People are like trees in their biological make up.'
Just as the buds on a tree will not and cannot open up an
Just as the buds on a tree will not and cannot open up an
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 blossom when the weather is cold, so a person cannot open and blossom to full human potential, cannot really be himself or herself, if the "people" enviromen
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in which he/she lives, is cold. A person cannot live creatively or share fully, whether that sharing is through talents, thoughts or feelings, in a "chilly" a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tmosphere where people do not care about, or only give perfunctory attention to one another, or where there is a hesitancy to express personal feelings and thou
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
hts openly for fear of rejection or rebuff or being laughed at. As most of us know, such an enviroment can be as disabling and as paralyzing and as bitter as a
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
temperature of five below zero.
Ask yourself some questions. Ask yourself how many people do you realy know? Spouses? Children? Friends? Probably you do no
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
really know them. True, you might be able to predict their reactions to certain situations. But do you really know them sufficiently to open up in a full sen
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
se?
What about yourself? Who really understands you? Who can you open up to? Who really wants to hear and share what you have to say or what you are feeling
What about yourself? Who really understands you? Who can you open up to? Who really wants to hear and share what you have to say or what you are feeling
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
at a particular moment? Who cares about your hopes, fears and what makes you happy or sad?
What about yourself to yourself? Are you frightened of the cold, d
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
ark places within -- frightened by what you might discover should you venture into the depth of your souls? Do you remain, like buds in the winter, closed and
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
aralyzed, never opening up, never sharing that inner richness that makes you unique and special?
There is an old story about "warm fuzzies" and "cold pricklie
There is an old story about "warm fuzzies" and "cold pricklie
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
s." These were metaphors for the different transactions that take place between people. For example, if someone paid you a compliment or offered a word of sup
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
ort or gave you a few moments of appreciation and understanding, it was said that your got a "WARM FUZZY," and made you feel a sense of warmth and peace. When
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
you got a cold shoulder, or a mocking laugh or a put down , that was a COLD PRICKLY, and you felt the cold of a barb hurled against you, and like the bud, you
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
closed up.
The symbols in the story teach us the need for nurturing. As the trees need sunlight and warmth to nurture them into budding anew, so we humans ne
The symbols in the story teach us the need for nurturing. As the trees need sunlight and warmth to nurture them into budding anew, so we humans ne
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ed the light and warmth of nurturing from others for our lives to be relevant and not just an existence. We need to be warm and caring to others and have a feel
.
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
ng of self-respect for ourselves. We need to be patient with the shortcomings of others and for ourselves. We need to learn how to praise those we live with a
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
nd show them appreciation for what they do or do not do as well as for who they are.
As the trees beautify our enviroment may we, too, make our lives beautiful
As the trees beautify our enviroment may we, too, make our lives beautiful
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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