Others - Writing and Speaking

There are ingredients of a good short story which we sense intuitively which are less tangible than those principles we can set down as 'rules' but ought to be picked up as we develop

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

as writers. I should like to consider a few of them here. The following points are not in any way intended as 'rules', they are rather intended to highlight aspects of writing which

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

Examples of combination products may in

affect the quality of the experience the reader has while reading our work.

Creating an alternative reality

To capture and hold a reader's attention a story has to take him or

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

her into a reality other than everyday life, and that reality has to be convincing. It we do our job well it will feel as convincing to him when he reads it as it felt to us while we

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

wrote it, and for this to happen we must believe in what we write. Our story must be, for us, a convincing recreation of reality refracted thorough our imagination and feelings.

We

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

Combination pro

ould liken the state of mind we need to achieve while we are writing to the mind of a child seriously absorbed in play; so engrossed in his game that it temporarily takes over from the

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

real world. Just as the child lives in the world of his game, so we live in the world of our story. And just as the joy of play for a child is that he can invent a reality which is a

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

mixture of the world as he knows it and the world as he would like it to be, so can we in our stories.

Feelings

When we look at why any particular story has made an impact on

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

us we nearly always find it has aroused our feelings in one way or another. We have related to the central character and been affected by the events which befell him or her and the w

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

ay he / she felt about them, perhaps in an intensely moving way, or perhaps in a subtle, clever, or humorous way.

A credible emotional dimension to characters prevents them from being

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

cardboard cut-outs. So our story must be engaging for the reader on the emotional level, and this means that we have to be engaged on the emotional level while writing it.

Integri

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

Following aspects would a

ty of structure

A story needs cohesion and wholeness. If we try to construct a story by fixing a number of bits together rather than letting it evolve according to its own intern

dd to the challenges in developing combination products:

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

al logic this will show, and the story will be stuck at the level of being the sum of a number of parts without being able to evoke a whole which is greater.

In this respect we can th

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

ink of a short story as being like a song. When a singer gets up to sing a song we expect the tune and the words to flow seamlessly together with no sudden jumps into different songs,

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

no discordant notes, and no flat passages where the tune disappears. The flow must keep going and all the parts must work together as a harmonious whole. If the flow stops, or any p

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

rts don't fit, the song will be spoiled.

It is of course unthinkable that the singer should stop the song part way through to explain what it means, or to fill us in with a bit of bac

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

Professional from academic institutions, pharmaceutical industries, health care indust

kground information. The meaning and whatever information is necessary to understand it must be integral to the song itself.

Confidence

We will also expect our singer to be c

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

onfident in his singing. Even if he is inwardly panicking we expect him to project an image of confidence. If he is hesitant and unsure of himself the song will be spoiled for us.

T

.

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

he writer must project a feeling of confidence. If the reader has doubts about whether the writer knows what he wants to say, or whether the writer has mastered words sufficiently for

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

Companies that provide selfless information through particip

to be able to make them say what he wants them to say, he may well look for another author who does.

Copyright: Ian Mackean
http://www.literature-study-online.com/creativewriting

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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