Top Adding - Writing and Speaking

One of the biggest problems that inexperienced writers have is simply knowing how to get started. If you’ve u

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

nsure of your writing skills, then here are some quick tips to help you get started.

1. Get yourself a thesau

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

Examples of combination products may in

rus—or better yet, two of them. These can be tremendously helpful tools when you’re struggling to find the ri

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

ght word. A thesaurus is no substitute for a solid vocabulary, but it is still helpful in a pinch.

2. Avoid

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

using the same word too frequently. This can make one’s work sound repetitive. Again, a good thesaurus can b

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

Combination pro

e helpful in this regard.

3. Keep your sentences fairly short, since longer sentences can sound unwieldy. I’

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

ve found that 17 words or fewer is a good guideline. Do remember that this is just a guideline, though.

4. E

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

ven as you keep the sentences short, make sure that they flow together well. Sometimes, unskilled writers wil

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

l simply chop longer sentences up into shorter segments that don’t blend together smoothly. If in doubt, try

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

rephrasing the sentences or adding the proper connective phrases (e.g. “then,” “so,” “as a result”).

5. Get a

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

copy of “The Elements of Style” by Strunk and White. It’s a short book, but incredibly helpful. There is no

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

Following aspects would a

better reference for aspiring writers.

6. Don’t rely too much on your word processor’s grammar checking feat

dd to the challenges in developing combination products:

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

ures. They can be quite impressive, but their capabilities are still quite limited. Spelling checkers are al

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

so limited in their capabilities, since they cannot recognize a lot of proper names and technical terms. In a

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

ddition, spell checkers cannot detect situations wherein the user has entered the wrong word in place of the 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

roper one.

7. Proofread, proofread and proofread… over and over. When you’re done, have a friend proofread y

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

Professional from academic institutions, pharmaceutical industries, health care indust

our work as well.

8. Remember your target audience. Ask yourself, “What information will my audience require

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

in order to understand what I’m saying?”

9. Avoid clever wordplay unless you’re sure that it will work. In

.

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

most cases, it is best to gain more writing experience before trying something witty.

10. Remember the artis

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

Companies that provide selfless information through particip

ts adage, “Practice, practice, practice”? If you want to become good at writing, then write, write and write!

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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