Encyclopaedia - Writing and Speaking

This article will take you through every step of learning how to write a book. From start, to plot, to editing, to finished manuscript, to getting it ready for the agent.

Volumes have been written to show you how to write

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

a book, so you know I won't be covering every step of writing a book in detail. For more information, look at the other articles in this series and for all the instruction you'll ever need make sure you sign up for the emai

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

Examples of combination products may in

l lessons at the bottom of this page.

First, decide whether your book will be fiction or non-fiction. Story, or how to.

Next, know how long your book will be. All non-fiction should be about 200 pages. 200 pages for ficti

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

on, too, unless you're writing in a specific genre.

Each book with have 20 chapters and each chapter will be about 10 pages in length.

Nothing is carved in stone, these are just some basic guidelines.

For your work of fi

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

ction, you'll need a plot. Only a fool will try to develop a plot from scratch. There are already so many plots out there that are ready to be used. Get hold of a bestseller in your genre that's about eight years old. That'

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

Combination pro

s the plot you're going to use. Change the names, change the places, change the scenes. If it's a futuristic science fiction, make it a period romance. If it's a western, make it contemporary.

Remember, Gene Roddenbury sol

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

d Star Trek to the Studio by describing it as "Wagon Train among the stars."

If you change everything except the plot, you're not plagarising anything and there's absolutely no problem with copyright.

Read the old bestsel

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

ler, divide the plot into 20 chunks, and you've got your new story.

Rewrite that book as quickly as you can, but don't look at the old bestseller any more. You already know what the story is. (And the market has already pr

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

oven it's a bestseller!)

For your non-fiction, remember, 20 chapters, 10 pages per chapter.

Read the non-fiction books on your topic out there already. There will be chapter topics common to all of them. These are the sam

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

e chapters you should put in your book.

Additional chapters should include answers to the questions you're always hearing from clients or others involved in the topic.

And make sure you include at least one chapter about

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

your own very special and unique 'technology' for getting the benefits the book topic offers.

That 'technology' strategy will be found in another article in this series.

In both cases (fiction and non fiction) write as qu

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

Following aspects would a

ickly as you can and complete your book immediately. The more deligently you work on your book before you start writing, the less work you'll find involved in the actual writing of your book.

And there are no points awarde

dd to the challenges in developing combination products:

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

d for the outstanding book you're going to write in the future.

Even the mediocre book you've written has far more value than the blockbuster that has yet to find the page.

That brings me to editing your book.

Two points

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

are essential for you here:

First, the faster you write, the more you will write the way you talk and that will give you a very sellable manuscript.

Next, you can't perfect something until it exists. Don't edit a single

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

word until you've got the manuscript finished. If you find yourself going back over a line you've just written, STOP and return to the writing of your book. No one is going to be reading this work until you're satisfied and

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

so your time is much better spent just completing the book, rather than spending the next year perfecting the first chapter.

Want to know how to edit your book? No problem. You edit your manuscript by following the cardin

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

Professional from academic institutions, pharmaceutical industries, health care indust

al rule about editing... Omit Needless Words.

If you have the time, go though each line and look at each word. Can it be eliminated, consolidated, or minimized? Can the sentence be made shorter yet still maintain impact?

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

Take any sentgence at all. Remove the needless words, and you've increased the power of that writing at least 100%

Here's the final element about your book you should know: It will never be perfect. There will always be fl

.

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

aws, pieces of story or information you should have included, suggestions by editors and agents that seem obvious when they're made.

Don't get bent out of shape about it. Make the corrections if you can make them. Live wit

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

Companies that provide selfless information through particip

h the wonderful published book (and remain silent) if it's already printed.

But whatever you do, start now, start today. Make it happen. There can truly be nothing more exciting or rewarding that getting that book written.

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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