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When I was thirteen, I went to the College of Magic, to learn all I could. It was kind of a Harry Potter school for stage magicians - there were rabbits coming out of hats, white doves flapping about and silk scarves that turned into ropes. I sat down eagerly to my first class, apprentice wi

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

zard that I was. I was told there is no magic. I was told it is all illusion, all trickery, all a sham. I couldn't have been more disappointed.

What followed were three years of interesting sleight of hand techniques, visual effects and misdirection. They were right; there was no magic in i

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t. They only used clever dyes, trick card decks and boxes with false bottoms. But I did not believe them that there was no magic at all. It was just that they had no magic to offer.

I believe in magic, and so I found a way to work with it, or rather, it found me.

Learning by Writin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

g Writing gives you the power to create. And as you create your tale, a man becomes a being, a character becomes a person whom you know, your creation comes alive as you spend more of your waking hours in their world. Writing is always a study of the human condition. I write what I

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

want to learn about, which is how to do magic. And so, I chose to write about a young wizard, learning her way in a world where magic is a raw force. By working with wizards, I begin to understand what it is they do, and how they do it.

Heightened Awareness Writing give

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s the writer a gateway to a deep and timeless realm. I call it Heightened Awareness. It is where the Muse speaks to me, and I feel wise and gifted when I am there, even though I know I shall lose that feeling the moment I walk out of the writing room door. It is what makes me come back, day

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

after day, to write. Engaging the Muse is like channelling a spirit. I speak to myself, and I hear a voice that is infinitely wiser than my own. It is hard to record the thoughts that flood down upon me. Too many thoughts, too rich, too elevated to grasp, sometimes.

Capturing thou

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

ght in metaphor Slowly, my ability to capture these thoughts improves, for they cannot be written in direct translation, but rather captured in metaphor, just as an impressionist painter strives to communicate the feeling rather than the form of what he has perceived. Anyone can wr

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ite a factual report ; the skill of writing fiction comes in the ability to write a net of words and ideas that contain the emotional and intellectual impact of the deeper idea within those bare sentences. The author's job is to prepare the reader's mind so they can be receptive to the deepe

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

r thought-forms when they come across them. There's a lot more to reading than the simple story.

Being Receptive to Magic Fantasy writing puts the reader in a world where magic is part of the accepted environment, and as you read you are in a receptive state. With just the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

right words, I can shift you to a place of seeing, a place of vision, where you experience the magic for yourself. The ability to bring that power back, to use it in this world, well that is true sorcery. Writing is the best way I know to work with that magic and to help others to step thro

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ugh the gateway, to see the unseen.

Exploring the story Stepping through the gateway (or falling into the page, as some would say) is a deeply moving experience. I am not the kind of writer who can plot out an entire book and then write it. My stories are written in darkne

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ss, they come from darkness; I have no idea of the structure of the house when I open the door. I strike a match, the candle flares, and then, I see ... And from there I explore, and learn, and discover. It's the way I enjoy fantasy novels, it's the way I want you to experience my story, as

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

I did.

Flash fiction The most inspiring pieces of writing came as flashes of visualisation, scenes I witnessed and then scrambled to record, with my fingers flying over the keyboard and yet still losing big clouds of exposition like smoke that scatters as I grasp for its t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

hreads. With the pivotal moments in the book I never feel that I am making them up - I have seen them, I am merely the (frantic) scribe. I feel priviledged to be sitting in a small chair in the front row of the action, and to have these heroes around me. I write as much as I can of what I se

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

e.

The Joy and Pain of Writing When I write I feel everything, I feel as my characters feel, I know their pain. Yes I shout and curse, yes I laugh, yes I cry. I feel as if I'm watching flashbacks stored in some giant astral database, things that have happened or shall com

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e to pass, and when I see them I am transported, as if I am a prophet or visionary. I am right there with them. If I could show my readers that, I know they will be completely gripped by the story. It would be like being in a 3D action film, and feeling the emotions and thoughts in

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

3D as well. Being in touch with the Muse is like stepping into a great mind. There is so much to explore down every train of thought, you feel there is so much beyond what you can touch that you could spend a lifetime learning and still know very little of the immensity.

Perfecting

.

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

the Spell of Fantasy Writing fantasy is very much like the art of perfecting a spell. The book is the spell, an intricate pattern of thought, woven around you. And it is a very real kind of magic. It is designed to transport you, body and soul, into another world. A world where you

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

can feel what the author felt, where you can see what the author has seen, and learn what they have learned.

Yet there is no place for me to feel smug about my learning, for there is another book, a new spell, and once again, I am the apprentice. There is so much to learn. And so, I write.

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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