References - Writing and Speaking

All of us are authors, and all of us have a book already written within us that needs to come out.

I believe that fiction is the easiest to write because none of what you write can, or needs to be verified and you are only limited by your imagination. On the other hand nonfiction requires verification of facts and the book usually has references to the material that you have us

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

ed. These facts can come from the documentation of others or your own. But the material is usually taken as truth or fact and supported by the documents you have used.

Then there is the Grey area that I write about… Philosophy! Philosophy always appears as truth and it is always controversial because in truth, truth is an illusion. My truth is not yours, and yours is not someon

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

Examples of combination products may in

else's. Philosophy can always be argued from one's point of view and it is nonfiction from that observation. From the position of the other it may be fantasy or imagination.

In truth, philosophically speaking, fiction and nonfiction are the same, as both come from the imagination and are subject to one's interpretation and the ability to manifest one's thoughts into physical s

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

mbols that are observable by others.

The wonderful thing about fiction is that the events become probabilities in physical form at some level of consciousness and are nonfiction. If I think of a lying under a palm tree on a white sandy beach on a tropical ocean one early sunny morning, that thought becomes your thought and the probability exists that either one of us can experi

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

nce it. It becomes a probability and only then needs to be experienced. All thoughts are the beginnings of any probability whether it is a sandy beach or Aliens attacking the earth.

The distinction between fiction and nonfiction is determined by our ability to allow our imaginations to accept them.

The Bible and other Holy texts are considered to be nonfiction, and yet they ar

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

Combination pro

the texts that are the least likely to be verified. The pages in these texts where written by many different authors, sometimes hundreds of years after the facts, if they did in fact occur, and the stories were selected for inclusion by people and organizations with an agenda. Many of the stories in the Bible were created to demonstrate aspects of morality and social behavior.

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

any stories have been left out deliberately.

We generally accept these books as historical facts because we were told to, even though critical thinking and reason suggests otherwise. Facts, truth and imagination have been blended into foggy images that transcend humanities ability to distinguish the difference, fueled by fear and ignorance. What is fiction, what is not?

We loo

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

k to an imaginary future and go back into the past to create it. Or we go back into the past to create a future book. The book the waits within you, is the future waiting to be created, it is already present in the moment and although it is nonfiction, it will be judged by others in the future as either.

Humanity has agreed at some level of consciousness to accept things as tru

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

h, or "nonfiction," if it is within the realm of possibility or if there is a strong human desire, want or need to believe it.

We as a people had a strong desire to fly to the moon and have done it, (maybe). We as a people have strong desires to create new technology and we do it, and we believe in technology because we can see it working. These areas are not that Grey, because

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

we want to believe. Predictions that we have made hundreds or thousands of years ago are now observable in our experience and easy to accept. Most believe that technology can achieve anything, from creating a sailing ship that moves past the abyss waiting at the edge of the earth, to the space ship that flies through it.

It is the same imagination that creates physical objects

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

r technology, which creates philosophy about who and what we are.

There is a strong desire within humanity, or need to believe and accept that there is more to us than what we can see, taste, smell, feel or hear. We have moved away from our ability to experience the soul and the mind as other parts of ourselves. We consider these aspects of self as fictional or beyond reach and

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

Following aspects would a

best left to the imagination of philosophers, priests and other self appointed experts. Most of us experience these aspects only when we read about them or attend presentations or Sunday services, as they are brought to our attention.

As one moves away from the philosophy of others and accepts their own truth as real and valid, then we are better able to accept all experiences,

dd to the challenges in developing combination products:

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

philosophies, and truths as truth. All probabilities and possibilities are valid and experienced at some level of consciousness. All fiction is nonfiction in the greater truth, and they are simply human or physical conventions.

I write my Nonfiction, Fictional articles early Sunday morning before I go for breakfast. In the course of the two hours that it takes me to write a 160

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

word article like this, I have my shower, get dressed, wash the dishes, take out the garbage and several other chores.

I do not give any thought to what I write about, and it just flows out of me naturally. When I sit down to the keyboard and monitor, my mind is blank and the harder I try to write something, the less the results. Most often I do not know what I am going to wri

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

te about before I start. I close my eyes for a few moments and try not to think about anything.

I accepted long ago that what I have to say or write about is valid, it has purpose and meaning. No matter how far fetched the words or thought, I try not to interfere and just let it come out. The fear of being crazy, stupid or uninformed left me long ago once I allowed the words to

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

come out. This article is philosophical (nonfiction) but it comes from a fictional thought process that I used to think was mine, it is not!

I encourage all those that come to me for guidance to just sit down and let it all out, no matter how outrageous, how unintelligent or gifted it may seem. No one has to read it, it doesn't have to be published, and you can tear it up when

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou are finished. By sitting down and starting to write, you will develop a process that works for you, you will be totally amazed at what you have locked inside. When I do read some of my stuff, I wonder, "Wow," was that me, that's not bad! Did I write that?

If you have visited my web site at klienwachter.com and read my articles you will remember that I have said many times I

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

rite for myself first and that is my truth. I do not have a need for others to read my words. I have however come to terms with my ego that wishes to be recognized as an author. I speak from the spiritual part of myself that is not physical and I agreed with my ego to allow it the freedom to publish and print these articles. We have made peace and the ego understands that recogn

.

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

tion my not come and that it is a probability that may or may not be experienced. On this we agree.

Spirit makes itself known or physically experienced through the words that are recorded for the benefit of the ego.

You have something to say, and your thoughts need to be expressed in the physical world and it is done in an infinite number of ways. Writing is just one way. But

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

Companies that provide selfless information through particip

o not back down because you believe your writing is not valid or important. Also realize that it may not be accepted by others and know that it doesn't really matter.

Write for yourself first and set your imagination free. Nonfiction is fiction finding expression and recognition in the physical world. It has no meaning except for the meaning given it by those who read the words

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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References - Writing Non-fiction

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