Others - Writing and Speaking

You have probably heard about the KISS principle, it simply means Keep It Simple

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

Stupid. Nothing is farther from the truth when it comes to writing books. It is

; 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 true for How to style books and certainly anything has to do with tr

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

aining. The general run besides simplicity is to write for the grade eight to gr

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

ade ten levels for all audiences. When I was doing writing for a large corporati

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

Combination pro

n, the materials were to be read by the top executives. I had to be particularly

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

careful to get to the point and put it in simple language. It was not because 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

he executives could not read, it was they did not have time to absorb more than

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

a few lines and get the point of the communication.

Most people do no

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

t take time to absorb technical writing unless it is part of their job or they a

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

e in the world of academics. I like to find books that are written so anyone can

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

Following aspects would a

understand what is being said and if it is a training manual, they will be able

dd to the challenges in developing combination products:

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

to put the topic to immediate use. When you write, find out who your audience i

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

s and then try to write for that audience. Leave your "methodologies" out of the

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

text unless someone else is doing a research project with you and you want them

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

to know you have a large technical vocabulary.

Any book should flow f

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

Professional from academic institutions, pharmaceutical industries, health care indust

rom one topic to another. Even chapters should make some sense for order. Often

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

books are dealing with complex subjects that need to be broken down in a manner

.

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

than is continuous. The chapters in this book were written as twenty separate ar

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

Companies that provide selfless information through particip

eas and although some of them are related, most are not. This was done by design

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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