Just Answers - Writing and Speaking

There are many writers who specialize in adventure writing and many who actually do the adventure and then write about it. Often the adve

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

nture that they experienced is further embellished in order to make it a worthy work of fiction to read. Some of the best fiction writers

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

Examples of combination products may in

seem to have lots of adventurous life experiences to draw from and then take their experiences and observations to a whole new level for

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

the reader.

Of course the love affairs are brighter, the action more intensive and the storyline and plot are thickened to make for an a

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

tion packed adventure. Recently, I have attempted to use writing in reverse. You see I want to travel the country by bicycle and accompli

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

Combination pro

h this in about 3-4 weeks. Once in my younger days about 15 years ago at age 25, I rode my bike from Oregon to Mexico along the Californi

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

a coastline to raise money for Special Olympics. It took 6.5 days and I rode in excess of 200 miles almost every day.

Now of course I ha

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

e this experience to draw from and I am using my writing to help me psyche up for the Trek Across America. I am writing each leg of the j

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

ourney as one online article. Writing the articles as I envision myself or a small group grinding out the ride. Power of the mind, it wil

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

help psyche me up. Still need to choose a route. I have driven nearly every road in this country that crosses each state in my Motor Hom

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

. Know all the hills, back roads, highways, freeways, towns, etc.

Indeed in my travels I have seen many long-distance cyclists out in th

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

Following aspects would a

e middle of no-where and listen to their stories when I see them resting; impressive group of folks indeed. Using this knowledge and conv

dd to the challenges in developing combination products:

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

rsations to help write the stories and articles.

Kind of practicing, as most likely I will write a book about the experience when comple

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

ted. I am still considering Running It, rather than biking it. Maybe both. Bike first for a warm up and then run it next summer; 3-4 mont

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

s to run it; 3-4 weeks to ride it; more about time and conditioning really.

Now this brings up an interesting topic to ponder. If you ca

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

use your experience to write fiction adventure stories, then can you use fiction adventure stories to help you fully experience and achi

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

Professional from academic institutions, pharmaceutical industries, health care indust

eve your adventure? Interesting thought as you can see.

Now then also lets consider Virtual Reality Training, Simulators and training ma

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

uals. You read and or experience prior to the events. Perhaps you see it in your mind. Why not use writing both ways. That is to say use

.

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

your writing to prepare for the adventure and your adventures and experiences to help you write. Continued Success in your Adventure Writ

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

Companies that provide selfless information through particip

ng and best of luck helping the reader feel as if they too are there with you or looking out from you or your main characters perspective

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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