Actual - Writing and Speaking

This is going to be my second article of many that I will be writing on how to break into the children’s writing market. This is going to be a c

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

onsiderably long series so keep checking back for updated posts.

Writing for kids can be one of the greatest ways to break into the writing fiel

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

Examples of combination products may in

. You have such a wide range of readers from toddler to young adults. All you have to do is figure out what you want to write about and you’re

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

n your way.

Chances are good that when you think of children’s books, picture books pop right into your mind. For the most part picture books a

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

e usually directed to kids from toddler to grade 4. One thing you have to keep in mind is that the book has to be appealing to the adults as wel

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

Combination pro

because they are the ones shelling out the money for them.

Picture books can range from a variety of different topics. You can have fiction, n

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

n fiction; they can be about animals, or about different people interacting with different stuff.

There is a basic format for picture books. Tr

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

ditionally there 32 pages long. That includes every page from front to back. Because of the pictures your story usually has to be told in 14 pa

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

es of print. Another thing to remember is that you usually only has around 1000 words to use to write your story. So you have to get a good sto

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

y in a small amount of space.

Picture books can be tough to write. So many people think that picture books are the way to go but soon find out

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

hat that’s not the case. You have to make sure that every word, picture and page has the most amount of detail that counts. You have no room fo

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

Following aspects would a

r unnecessary content.

Just because you’re intended audience is youths doesn’t mean every word in your book has to be 4 letters long. Remember

dd to the challenges in developing combination products:

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

ts going to be the parents for the most part that are reading the books to their youngsters. Also there is a misconception that all picture book

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

must be rhyming. This is in no way true. As long as you develop a great story rhyming is nice but doesn’t really matter.

Chances are if you t

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

ink about it then it has been written about already. That’s okay for you to go ahead but you have to find a fresh new way to present the idea.

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

ou have to make the publishers want to use it.

Don’t worry if you can’t draw. The editors want to first see if your book can stand on its own w

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

Professional from academic institutions, pharmaceutical industries, health care indust

th out the pictures. If at that time they decide they like it they will hire an illustrator to help with the pictures. You have to remember tha

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

when you are writing a picture book it’s not only about the words. The colors and scenes have to be vibrant. They have to stand on 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

Before you attempt to write your first picture book make sure you go to your local library or book store and read several different books by seve

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

Companies that provide selfless information through particip

al different authors. No one wants you to plagiarize but by studying different styles you can than begin to develop your own style.

Dale Mazure

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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