Social Articles - Writing and Speaking

Are you crazy? If you're shaking your head yes, smiling to yourself or laughing aloud, honestly wondering when you will stop talking to the walls in your office o

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

n those days that you stare at a blank computer screen for hours hopelessly trying to find a flawless opening sentence for a perfect beginning or a clever combina

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

Examples of combination products may in

ion of words to carry you to the ultimate ending of your work in progress - You're definitely already a writer by my definition...

If you think I'm crazy for sug

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

esting you're crazy for wanting to be a writer, you're probably right. I am admittedly not a completely sane person. I am a writer. I do love being a writer. I al

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

o know that being a writer can be one of the most rewarding professions some days and one of the most frustrating pursuits other days.

A perfect day in my life o

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

Combination pro

curs when my fingers bang on the keyboard furiously trying to keep up with the surge of ideas and words flashing in my mind as some exceptional creative thoughts

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

onnect with my ability to put it all into words effectively. I treasure those hours when inspiration, insight, talent and determination merge together to allow me

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

to write proficiently.

Unfortunately, many days do not develop that way. Picture this - A blank computer screen, a blank stare, a glance out the window, a curse

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

hispered to yourself, a bathroom break, a day dream in progress, a mind devoid of creativity, a lack of artistic emotion, a discussion with yourself aloud, a litt

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

e scream of frustration, a request for input from the walls that surround you, a demand for a solution to get your writing started on this day when no words seem

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

o work together - no feelings seem to want to flow from within your frustrated brain... The harder you try the less you accomplish.

Why is writing so difficult f

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

Following aspects would a

or you today? You ask the question aloud. You wait for the walls to answer. They fail you too...

As long as you don't answer yourself, you're not certifiably ins

dd to the challenges in developing combination products:

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

ne. You're just experiencing the dreadful dilemma commonly known as "Writer's Block."

How can you deal with this annoying obstacle? There are no solutions guaran

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

eed to succeed for everyone. I can offer a few simple suggestions that have worked for me. Idea #1 - Turn off your computer. Get out of your office. Go for a walk

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

outside.

Idea #2 - Walk away from your computer. Read a book, your favorite newspaper column, or a new magazine article that you've been meaning to look over.

I

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

ea #3 - Get up from your desk and stretch. Close your eyes. Slowly extend your arms to reach for the stars. Breathe. Relax. Concentrate on reducing the tension in

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

Professional from academic institutions, pharmaceutical industries, health care indust

your muscles. Clear your mind. Repeat until you feel less stressed and ready to re-focus your energy.

Idea #4 - Leave your office and shut the door. Get out the

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

acuum cleaner. Clean your bathroom. Wash your dishes. Scrub your kitchen floor. Do some sort of housework that will make you feel like you accomplished something

.

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

orthwhile today.

Idea #5 - Get out of your office. Turn on the television, kick back in a comfy chair and watch your favorite soap opera. Turn on the radio or po

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

Companies that provide selfless information through particip

in your favorite CD and dance or sing along. Let it out.

Feel free to adjust these remedies to suit your personal preferences. Whatever works is the bottom line

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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Many companies screen the employees before recruiting them. This helps them weed out undesirable candidates at the outset. It also protects them from litigation, regulators and the risk of high turnover.

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