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E-Articles - Increase Your Presence
Past is dead
Future is not born yet.
What-so-ever is…is only the present. To be present with the present is the greatest gift you can gift yourself. As, past is memory Fu 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 ture is a fantasy
And only the present is real.
To be present with the real is to welcome life, hug life, and receive life. Mind can only survive in the past and the future ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in .
There are no thoughts in the present moment.
Heart is capable of being in the present.
The way to live a heart centered life is to be totally in the present moment.
Ther lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ’s clarity.
In clarity, the clutter and clouds of thoughts fade away. What takes you away from that clarity? Membership to “Club 99” What’s club 99? Here’s the story for here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe you. Once upon a time, there lived a King Who, in spite having his luxurious lifestyle, Was neither happy nor content. One day, the King came upon a servant who Was si d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro nging happily while he worked.
This fascinated the King;
Why was he, the Supreme Ruler of the Land, unhappy and gloomy?
While the servant had so much joy.
The King aske 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 the servant, "Why are you so happy?"
The man replied, "Your Majesty, I am nothing but a servant,
My family and I don't need too much –
Just a roof over our heads and warm 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 food to fill our tummies." The king was not satisfied with that reply. Later in the day, he sought the advice of his most trusted advisor. After hearing the King's woes a nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically nd the servant's story,
The advisor said,
"Your Majesty, I believe that the servant has not been made part of The 99 Club."
"The 99 Club? And what exactly is that?" the Ki 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 g inquired.
The advisor replied, "Your Majesty, to truly know what The 99 Club is,
Place 99 Gold coins in a bag and leave it at this servant's doorstep." When the servant s ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi aw the bag, he took it into his house.
When he opened the bag, he let out a great shout of joy...
So many gold coins!
He began to count them. After several counts,
He w ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a as at last convinced that there were 99 coins.
He wondered, "What could've happened to that last gold coin?
Surely, no one would leave 99 coins!"
He looked everywhere he dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ould, but that final coin was elusive.
Finally, exhausted, he decided that
He was going to have to work harder than ever to earn that gold coin and
Complete his collecti cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin on. From that day, the servant's life was changed. He was overworked, horribly grumpy, and Castigated his family for not helping him make that 100th gold coin. He stoppe tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen d singing while he worked.
He was stressed out to complete his collection of 100 gold coins. Witnessing this drastic transformation, The King was puzzled. When he sought 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 his advisor's help,
The advisor said, "Your Majesty, the servant has now officially joined The 99 Club."
He continued, "The 99 Club is a name
Given to those people who ha ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ve enough to be happy but are never contented,
Because they're always yearning and
Striving for that extra 1, telling to themselves:
"Let me get that one final thing and y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products then I will be happy for life." We can be happy, even with very little in our lives, But the minute we're given something bigger and better, We want even more! We lose our . 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 sleep, our happiness,
We hurt the people around us; all these as a price for our growing needs and desires.
That's what joining The 99 Club is all about." We never have w elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip hat we like, We never like what we have. Still, we hope that someday, we'll get what we love or we'll love what we have! May you be radiantly present 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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