Social Articles - Writing and Speaking

When we write stories, with the purpose of sharing them with others, we enter into an agreement where we allow our reader to see a glimpse of our heart, our souls and our memories. If we truly want th

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

em to be immersed in the tale, we actively immerse ourselves in those memories so that a glimmer of what we saw, heard and felt comes through.

This is especially true with holiday tales. The best way

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

Examples of combination products may in

to convey a holiday scene is to take a trip back in time through the wonderful world of our unconscious. Here are some great ways to delve back into our child hood memories and incorporate them into o

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

r holiday tales.

1) Sit in a darkened room and close your eyes. Allow yourself to go back in time to the very first Christmas that you can remember. Take a deep breath and relax. What are the scents,

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

sounds and feelings that come up? What is the first picture that pops into your mind?

Is it the sound of children racing down the stairs that comes to you first? The feel of your heart pounding when

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

Combination pro

ou awoke and found that Christmas was really here? The warmth of your parents’ blankets as you bounced on them, anxious to wake them up?

The autumn and winter holidays will always be associated, for

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

me, with my grandmother’s cooking and pumpkin pies. I remember running into her little house, and the sound of the front door’s slam behind me. I was immediately engulfed in warmth. The scent of nutm

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

g and cinnamon and pumpkin seeds physically drew me forward, until I was wrapped in my grandmother’s embrace.

2) Recreate the scene. Since a prime trigger for me is the scent of pumpkin pies, I often

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

order pumpkin scented candles from Yankee Candles. I sit on the couch, wrapped up in a blanket, light the candles and wait. Within moments, the scent has pulled me back to my grandmother’s kitchen. An

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

I hear the sound of my cousins pounding down the hall after me, each of us anxious to win the first warm treat.

You can do the same. If a scent triggers your memories, you can either bake the cake o

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

cookie or brew the eggnog. Or you can get one of those scented candles and simply light it.

If the feel of sweaters immediately transports you back to your snow throwing days, slip one on. If you ar

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

Following aspects would a

e like me and live in Florida, turn the air way up first. Close your eyes and hear the sound of children shouting as they try to nail each other with snowballs. Picture their fresh flushed faces.

3)

dd to the challenges in developing combination products:

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

f there is a particular holiday character that sparks your memories, rent holiday movies. Some of my favorites are Frosty the Snowman and Miracle on Thirty fourth street. Watch one for a while, until

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

you get the holiday feeling, then turn the sound off. Watch the pictures and let your mind go.

4) Use all of these pictures and sensations and feelings in your story.

If you are writing about a litt

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

e girl in a big family, think back to what holiday dinners were like for you. Did everyone talk at once? Does your character like this or does she feel overwhelmed? What is it like to be the smallest

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

ne in a room full of adults? Is there a cousin or neighbor that is constantly picking on her? Do the children get bored and decide to explore the forbidden attic?

5) Once you have a scene in mind, w

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

Professional from academic institutions, pharmaceutical industries, health care indust

rite down all of these questions. Don’t worry about answering them until you have run out of questions. Then think back to the picture, sound or feeling that you associate with and answer the question

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

.

6) Now describe everything that you can about the characters. What are their ages? What do they look like? Are they the youngest or oldest in their family? Where do they live? What is their favorit

.

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

thing? What are their best friend’s names? Who is their arch nemesis and why?

Get as much detail as possible down.

Once you can describe all of these things, the pieces of your story will begin to

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

Companies that provide selfless information through particip

all into place. More importantly, your characters and your scenes will be real and alive. Be brave and put as much of yourself into these stories and your characters. Your readers will love you for it

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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