Useful Articles - Writing and Speaking

Writing doesn't have to be hard; in fact it can be as easy and natural as spoken conversation. All writer's struggle in the beginning to develop creativity and flow; use the following seven tips to sharpen your tal

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

ent and reach your goals.

1. Carry a notebook

Carry a notebook with you at all times; when inspiration hits, seize it and your notebook with both hands. All writers recommend carrying a notebook; use it fo

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

Examples of combination products may in

r the surreptitious jotting of thoughts when and where ever they might appear.

Jack Kerouac, foremost writer of the Beat movement of the 50's and '60s—a moniker and eminence he was deeply uncomfortable with—carrie

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

one everywhere, forever sketching poetry and novels to be in the most unlikely of places—"Scribbled secret notebooks, and wild typewritten pages, for yr own joy" in his words. Likewise Walt Whitman, 19th Century '

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

Father of American Poetry' and inspiration to Kerouac, who went one step further and carried an entire manuscript, a paperweight sized bundle that would one day be his "Leaves of Grass."

2. But use it in the ri

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

Combination pro

ght place

Funnily enough, this oft revised and reworked masterpiece was the cause of Whitman's dismissal from at least one job—fired from the Department of the Interior by an enraged employer upon closer inspe

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

tion of the 'paperwork' on his desk. Which suggests that some places are better to write in than others, although in Whitman's defence, most writers can relate to the truth that inspiration may strike in the most u

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

nexpected places.

3. Make writing a good habit

Writing is a good habit which can benefit from a little encouragement. To this ends, many writers recommend a specific place to write, almost like a meditatio

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

n shrine, dedicated to this solo, inspirational practise. For some a specific time of day is conducive—a daily regimen just like eating, sleeping and exercise. Creativity can wax and wane like the passage of the mo

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

n; take time and place of writing as two aids to assist obstructing clouds to part.

4. Regularity builds the muscles of writing

Make an attempt to write every day, without thought or judgement for the qual

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

ity you produce. Writing is like a creative flow; it will not begin if you do not turn on the tap. One method is to write like a river bursting its dam, words spilling over onto the paper before you. Follow the riv

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

Following aspects would a

ers' flow as far as you can, and in time the distance you travel will grow. Look not at this metaphorical river's banks or rocks ahead of you; flow forth like water, always moving.

5. Writing is like meditation

dd to the challenges in developing combination products:

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

/b>

Writing can be like the act of meditation itself, a secret known to centuries of haiku poets who were also meditators, and practised it as such. Write regularly, in silence and with one-pointed focus to achiev

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

e your goal. Furthermore, the discipline of regular practise, as in meditation, encourages an ever deepening flow of creativity, and a more fruitful, productive experience.

6. Suspend critical thought

Susp

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

end judgment during a first draft, even if your mind screams that you are writing poorly. More important is to write, write, write; regardless of quality let the words pour upon the page—revising and polishing are

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

or a later date. The editing process is a different mindset from that of writing, which requires creativity to flow directed but unimpeded; for the sake of creativity leave this more critical part of your being to

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

Professional from academic institutions, pharmaceutical industries, health care indust

one side. It is not without reason that professional writing seldom sees the occupations of writer and editor in a single person.

7. Exercise your body, not your mind

Running, and exercise in general, will

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

actually help your writing. Meditation teacher Sri Chinmoy calls running meditation for the body; it clears the mind and purifies the emotions in the manner of a breath of fresh air, dispersing anger and depressio

.

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

as though clouds in the sky. Negative qualities are an anathema to creativity—it's total polar opposite; take physical exercise as a simple tool to clear the road ahead when you are writing. It also makes a good t

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

Companies that provide selfless information through particip

ime out.

Writing is like running in a sense; the hardest part is getting under way, but once started a momentum is built which will carry you along. Surrender to this and your writing may one day become effortless

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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