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Completing a novel is one of the most satisfying events of a person’s life. Your blood, sweat and tears have been combined to create what you feel is the Great American Novel. Friends and family

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

sing its praises and you can’t wait until it’s glossy cover is displayed in bookstores all over America.

The reality, however, is that the majority of completed novels never make that coveted tr

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

Examples of combination products may in

ansition from manuscript pages to published book. Publishers have become increasingly picky about what they choose to purchase, and landing an agent has never been more difficult.

So how do you

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

know if your novel has a chance in this inflated market of completed manuscripts? It must have commercial appeal.

Publishing houses look at each new manuscript as a gamble. They are assured of

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

uccess when it comes to publishing novels by Dean Koontz, Stephen King, Anne Rice and Robin Cook, but when a previously unpublished author captures their attention, they can’t be sure that thei

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

Combination pro

r target market will be equally enthralled.

In order for a novel to sell well, it must have commercial appeal, which means that it is attractive to a wide commercial audience. What types of no

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

vels are people reading these days? And will they find this novel exciting and fresh?

Unfortunately, the novels that sell that best are the ones that are carbon copies of everything else on th

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

market. Formulaic writers do best because their readers always know what to expect. When you pick up a Stephen King book, you know that terror and gore will run rampant. When you browse the sh

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

elves for Dean Koontz, you’re assured that each volume will contain a love story and suspense.

In many ways, writing books is just like running a business. You must be able to identify your targ

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

et market and give that demographic exactly what it wants. Each new author must have a niche and must reside in that niche for the rest of his or her career.

A novel with commercial appeal may

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

fit into many different molds, but if you’re a new and aspiring author, look for these qualities in your finished material:

Broad Audience. A novel that appeals to a narrow audience can’

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

Following aspects would a

t sell well, so you might as well put the project away. In order to have commercial appeal, a novel must find its way into the hands of a diverse audience. Make sure, as you’re writing, that you

dd to the challenges in developing combination products:

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

r prose doesn’t lend itself to one set demographic. If it does, you’ll need to find ways to broaden it.

Well-Defined Plot. One of the most common reasons for rejections in today’s publish

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

ing industry is poor plotting. If you can’t create a storyline that speaks to the reader – and that holds the reader’s attention – you can’t hope to find a publishing house. A tightly-woven plot

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

with no holes and no margin for question is the key to creating commercial appeal.

Interesting Characters. The world is full of different people; no two of us are exactly alike. Another r

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

eason why novels are rejected is because of poor characterization. If your characters don’t have interesting histories, intriguing occupations and realistic habits, your audience is going to reac

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

Professional from academic institutions, pharmaceutical industries, health care indust

h for the next title on the shelf. Publishers know this. So do yourself a favor and create commercial appeal through characters that charm and mystify the reader.

Relevant Content. Writin

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

a novel to which no one can relate is akin to career suicide for a writer. People watch movies, listen to music and read books because they want to experience something that relates to their own

.

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

lives. Give your readers what they want by writing a novel to which your readers can relate.

Unfortunately, your novel might not have commercial appeal, in which case you will need to rework i

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

Companies that provide selfless information through particip

t. Look for ways in which you can improve upon the prose as well as the structure and characters. And above all, read as often as you can to get an idea for what the marketplace wants – and lacks

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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