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Write You - If Failure Is A Dirty Word - It Pays To Know How To Clean It Up!
The flip side of the success coin is failure. In our culture, failure has almost become a taboo subject - and yet failure simply means lack of success. Learning from failure to gain the
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
success you want isn't magic - it's called planning. In writing this is crucial, so let's have a look at some pointers.
Planning is the key to success in many walks of life and in most
Planning is the key to success in many walks of life and in most
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
careers and writing is no exception. If you are planning who to write for, have the correct target market, write the correct sort of material for that market and most importantly NEVER
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
GIVE UP - then eventually (maybe the next story?) you WILL make the breakthrough!
Motivation of the self is not easy - I wouldn't insult your intelligence by pretending it is. This is o
Motivation of the self is not easy - I wouldn't insult your intelligence by pretending it is. This is o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e reason I advocate going to a good writer's group - the support you receive may well make all the difference between becoming a published writer and throwing in the towel in disgust!
S
S
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
urveys have shown that over 70% of people questioned have put 'writing a book' in their all-time top ten of things to do in life. What they don't show is how to go about doing it! Look a
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
t this way: Learning to drive a car is quite an achievement - being in charge of and responsible for over a ton of metal on the move is a serious business.
Yet millions of people can dr
Yet millions of people can dr
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
ive cars, despite the learning curve that it involves - so why can't they write that longed-for book? The answer lies in one word: tuition. Someone actually teaches you to drive that car
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
- how it goes, how it stops, how to make a left turn, when it's safe to overtake - the list goes on and on. In fact, learning to drive is SO difficult that the real surprise is that so m
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
any people manage to do it at all!
So where do you find these tutors? Driving instructors fall out of the trees everywhere you look - but who is going to teach you how to write your boo
So where do you find these tutors? Driving instructors fall out of the trees everywhere you look - but who is going to teach you how to write your boo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
k?
Above I mentioned writer's groups. Belonging to a good one, where members aid each other and help is always at hand, is pure gold. But what about the times you can't attend, or it's
Above I mentioned writer's groups. Belonging to a good one, where members aid each other and help is always at hand, is pure gold. But what about the times you can't attend, or it's
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
not group night? There you sit; despondent and demotivated, realising that writing can be a very lonely job indeed. Maybe you turn to a 'how-to' book - maybe you look inside yourself for
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
inspiration.
The point is that if your work is planned from start to finish you should never, ever dry up. So-called 'writer's block' usually occurs during the writing of a book because
The point is that if your work is planned from start to finish you should never, ever dry up. So-called 'writer's block' usually occurs during the writing of a book because
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
you have hit a point where the plot is falling apart (due to lack of planning) and your back is against the wall with nowhere to go.
If, however, you plan your work in advance this won
If, however, you plan your work in advance this won
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
't happen as all the bugs get ironed out of your story before you actually write it. You have probably heard the old mantra 'fail to plan, plan to fail'? Well my mantra is 'plan your fin
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
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
ish and finish your plan'!
It really is that straightforward. Not easy - very few things that are worthwhile are easy - but achievable. Also, when you have an end in sight it's so much
It really is that straightforward. Not easy - very few things that are worthwhile are easy - but achievable. Also, when you have an end in sight it's so much
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
asier writing your story - after all, you know just how close you are at any given time to that cliffhanger ending! So planning is the the key to overcoming failure - it unlocks the door
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to good practice in writing your story and lets you get on with the writing without having to worry about the plotting - because you did that already!
In summary, always treat failure
In summary, always treat failure
.
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 there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
- that rejected story for instance - as an opportunity to question your working methods. Did you indeed write the correct sort of story for your potential readers? Did you plan everythin
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
g out about your story before you started writing? If you didn't do either of these - put it right next time and the chances are far higher of that acceptance letter hitting your doormat
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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