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You have finished your dissertation. It has met the approval of your committee. They have encouraged you to get your work published. You mail your dissertati

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

on to several noted publishers in your field. The dissertation comes back with a rejection note. You are discouraged.

But you can have another ending. A hap

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

Examples of combination products may in

pier ending. If you take the time to convert your dissertation into a book manuscript.

Following the steps below can turn your sadness into joy when your book

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

manuscript is accepted.

STEP 1 - THINK BEFORE YOU WRITE Your dissertation is a scholarly manuscript. You are now writing for a broader audience. Think abou

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

t how you can make your manuscript appeal to more people.

STEP 2 – REREAD YOUR DISSERTATION Reread your dissertation with an eye as to what can be taken out.

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

Combination pro

What do you think needs to be added now that you do not have to please your dissertation committee? Can your topic be tied to a current issue of interest?

STE

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

P 3 – DEVELOP A SCHEDULE You are going to have to approach this project with the same dedication you applied to writing your dissertation. However, you now ha

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

ve more responsibilities. A job. A family. Friends. All are vying for a share of your time. Devise a workable schedule for this project.

STEP 4 – GET COLL

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

EAGUES OPINION Ask your colleagues to read your dissertation with an eye for it becoming a book. Record their comments. What needs to be added? What should

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

be taken out? What needs further explanation?

STEP 5 - WRITE INTRODUCTION Write the new introduction to your book. Make it as strong as possible. Rewrite i

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

as many times as necessary. The introduction is what will make an editor want to read your manuscript.

STEP 6 – DEVISE A NEW TITLE FOR YOUR MANUSCRIPT A boo

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

Following aspects would a

k title is very important. It describes what the book is about. It makes readers want to pick up your book. Make your title clear. Make it grab the interest

dd to the challenges in developing combination products:

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

of readers.

STEP 7 – DO MORE RESEARCH Complete additional research needed for your book before you begin writing. If new chapters are added make sure you ha

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

ve all background materials needed. Doing needed research beforehand will make the writing of your manuscript easier.

STEP 8 – REWRITE THE TABLE OF CONTENTS

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

The table of contents for your dissertation is different than the table of contents for a book. The table of contents for a book serves as a blueprint for its

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

ontents. It is the road map that will guide you all the way to the end.

STEP 9 – WRITE EACH CHAPTER Write each chapter of your book. Make each chapter of ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

nageable length. A 50-page chapter is too long. Present the material in each chapter in a clear, concise manner.

If you follow the steps outlined above you s

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

hould be able to convert your dissertation to a book manuscript. It will take time and dedication on your part. But it can be done. The additional months s

.

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

pent on this project will be well worth it when you open your mailbox and inside is a book contract from a publisher.

Margaree King Mitchell is the Co-owner of

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

Companies that provide selfless information through particip

MKM Book Services, a book-consulting firm. Converting dissertations to book manuscripts is one of the services offered. Her website is www.mkmbookservices.co

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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