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Do you want to write a book? It is a big task so you need to be ready for it. I

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

f you are inexperienced you may want to gain valuable skills by writing short a

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

Examples of combination products may in

ticles or stories first. Writing a book can be a monumental task which can stre

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

ch you time, energy and nerves to the limit.

You can gain experience before yo

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

settle down and write your first book, by submitting work to print publication

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

Combination pro

s to see if you can actually sell your writing. Then if you want to write books

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

this will gain valuable experience and exposure which can help you with such t

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

sks as querying and submitting longer works. You may need skills to enable you

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

o deal with rejection - it will happen! Most writers experience more rejection

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

than acceptance.

Perseverance is important. Talent counts, of course, but by d

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

aling with rejection then asking "why" you will grow a thicker skin and be a be

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

Following aspects would a

ter author in the end. Not everyone will like your standard and style of writin

dd to the challenges in developing combination products:

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

. Don't give up as you receive each rejection - persevere until you get it righ

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

t. Pick yourself up and try again. Sometimes over and over again.

You will hav

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

to adapt and become comfortable working with an editor to get your story or id

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

as into a format that will sell. Publishers are not in the game for fun - they

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

Professional from academic institutions, pharmaceutical industries, health care indust

re in it for profit. They have more experience than you. You are the author but

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

the editor knows the audience. He can help you progress - listen to what is sa

.

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

d. The alternative is self-publication but there are issues with this, not leas

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

Companies that provide selfless information through particip

of which is not having the backing and muscle of established publishing houses

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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