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Many times, new authors receive feedback that surprises them. Of course their heroine isn’t too stupid to live, what makes this reader think that? And in no way did they imply

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

the hero was a wimp, where did they read that?

It’s not unusual for a first manuscript to be riddled with contextual errors that give readers the wrong impression. This occurs

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

Examples of combination products may in

especially when a new author wishes to convey their character in a certain way and includes descriptions, events or flashbacks that they believe showcase their character’s per

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

onalities. Not such a bad idea, you may think, but where does this create the problem?

For most writer’s, once they’ve learned the difficult technicalities of the craft, the n

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

ext major leap is plot and character development. Why do I mention these two as ONE step? Because they have to go hand in hand. You cannot separate one from the other. Those de

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

Combination pro

scriptions, events, and flashbacks MUST directly relate to the plot, or they fail and give the reader the wrong impression.

If Mary is a good girl, and a new author decides to

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

throw in a scene where Mary is helping an elderly lady across the street–they must make this relate to the plot at some level. If the story is about a woman who helps an elderl

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

y lady across the street only to discover the woman has played upon her kindness to get her into a darkened alley where she can be mugged, then it’s integral to the story. But,

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

if the story is about the New York Stock Exchange and Mary’s scene of kindness is only to show Mary as being kind, then the scene fails to move the plot forward and needs to b

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

deleted.

You may be arguing with me at this point that character development does move the plot forward. And I would reply that it definitely does. But, there doesn’t need to

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

be an entire scene devoted to showing this character development. Mary’s kindness could be shown through a quick exchange of dialogue with another character:

“Mary, if you ha

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

Following aspects would a

d two broken legs, you’d still help an old lady cross the street. You’ve got to toughen up. The New York Stock Exchange is no place for a nice girl like you.”

Not every idea w

dd to the challenges in developing combination products:

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

have works for our story–not every bit of the history we’ve given our characters will make it into the story. When in doubt, ask yourself if you can either rewrite so the scen

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

e pertains to the plot, or if the information given could be shown better in dialogue from another character. Remember, for a character to think about themselves as kind, beaut

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

iful, handsome, strong, brave, or another personality trait, never reads nearly as strong as if another character offers that information to the reader.

With the above informa

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

ion in mind, create a mission statement for your protagonist(s). This mission statement should cover both the character development and the plot. Here is a mission statement fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r my heroine in Stark Knight:

Sara Stark will bring to justice the man who killed her father and stop him from killing anyone else. (This covers the plot) Sara will discover i

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

f she’s capable of loving and trusting the man she’s called brother most of her life. (This covers the character development.)

This mission statement will help keep you focuse

.

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

. Does the description, the event, or the flashback correlate directly to the mission statement? If it doesn’t, rewrite or delete the scene. Once this is accomplished, the chan

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

Companies that provide selfless information through particip

ces a reader will get the wrong impression of your characters or your story, are much less likely and the chances of achieving the sort of feedback you long for will sky rocket

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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