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Your Space - Universal Alignment
When the Universe is aligned, all things are possible.
Kismet, Karma, Synchronicity and Serendipity work together in unison to provide for us when we sometimes le
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
ast expect it. Often it is there, but we are too blind to see. Blinded by stress, our jobs, our finances or our illnesses, we often miss what is right there in 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
nt of us.
If you are searching for something, wishing or dreaming for a certain reality, the Universe will open to you―if you are open to it. Patience and f
If you are searching for something, wishing or dreaming for a certain reality, the Universe will open to you―if you are open to it. Patience and f
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
aith are an integral part to getting where you want to be. You may believe it is the right time, right place, but the Universe knows best.
There once was a young
There once was a young
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
girl who dreamed to be a published writer. Every day she wrote, every week she sent out query letters and samples of her work, only to be rejected repeatedly. Even
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tually she gave up on her dream…her faith had died and her patience had dwindled into nothingness.
Many years later, she realized that she was still a writer̵
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
3;nothing more, nothing less. Every job she had acquired had developed her writing abilities and skills. And her soul yearned once more to be what she most desired
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
―a published author. This time, she sent out inquiries, investigated the field using skills she had learned in the last twenty years. She utilized the Intern
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
et and researched the markets, publishing companies and numerous sites.
Then she began to write the novel that had been 'haunting' her for two years. Within six w
Then she began to write the novel that had been 'haunting' her for two years. Within six w
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
eeks, she had a publisher, and within just over three months, her novel was complete. It was published shortly afterward. Success!
Some people have asked her: "Wh
Some people have asked her: "Wh
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
y now? Why were you published now?"
When I was younger, the Universe knew that I had talent but that it needed to be developed by experience. Reading my past work
When I was younger, the Universe knew that I had talent but that it needed to be developed by experience. Reading my past work
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
s, I agree with the Universe.
How could I write about death when I had not experienced death? How could I write about loss when I had never lost anyone dear to me
How could I write about death when I had not experienced death? How could I write about loss when I had never lost anyone dear to me
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
? How could I write about love when I had only experienced teenage infatuation, not the kind of love that would make you sacrifice everything―even your life?
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
The Universe knew the exact moment that I was meant to return to my passion of writing. The plan was there all along―I just simply couldn't see it. But I w
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
as led to a friend who did see it, who encouraged me and inspired me to write a story that needed to be told. It would not have been the same story if told years a
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
go before I was ready, and before the Universe was ready for me.
Now I am ready! My time has come!
The Universe aligns itself in such a way that impossible is ma
Now I am ready! My time has come!
The Universe aligns itself in such a way that impossible is ma
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
de possible. Just as a baker requires proper ingredients, carefully measured, and the correct temperature, we must sometimes wait for everything to be 'measured an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d correct' before we see the ultimate plan. Patience and faith! If we have both, great things can be achieved. The alignment of the Universe may take months...or y
.
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
ears. But guard yourself against allowing the opportunity to slip through your fingers. Keep yourself focussed, be persistent and above all, have faith.
When the
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
Universe is aligned for you, you do not want to miss it.
When there is Universal alignment, ANYTHING is possible!
©2004 Cheryl Kaye Tardif
When there is Universal alignment, ANYTHING is possible!
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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