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Others - Writing A Story? Enjoy Yourself And Follow These Basic Rules!
Fantastic news, you’ve finally taken the plunge, I know you wish you’d done it years ago, but a spouse, three kids, two dogs, a
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
full time job etc, etc, ……aarrgghh!! Tell me about it! Better late than never is what I say.
Is it a novel, perhaps a short story? It could be y
Is it a novel, perhaps a short story? It could be y
; 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
ur autobiography or even an article for a magazine/newsletter. Regardless of the content, nature or intensity of your writing make your self one
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
promise …enjoy it! So many would be writers fall at the first hurdle, not through lack of talent, effort, commitment or endeavou
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
. It is almost always a lack of planning that proves to be the major stumbling block.
The first and most important area to work on is st
The first and most important area to work on is st
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ucture. This brings together all the individual elements associated with your story in an organised manner, these include;
Your
Your
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
characters and their interaction/dialogue – conflict, humour, misunderstandings etc.
The overall theme of you
The overall theme of you
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
story – good versus evil is usually a good one.
The major plot – that’s up to you!
Any sub-plots –
The major plot – that’s up to you!
Any sub-plots –
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
skeletons in cupboards, vendettas, unrequited love, you get the idea
Location/setting/timescale – where and when? Time span – h
Location/setting/timescale – where and when? Time span – h
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
w long is your story? More important for short stories
A sting in the tail – keep them guessing right to the end!
Remember thi
A sting in the tail – keep them guessing right to the end!
Remember thi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is only a guide, the suggestions above outline some of the proven key points but it is your own individuality, creativeness and imagination that
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
really counts.
Think about your favourite books/stories for a while and you will notice that apart from the subject matter, the structure, as o
Think about your favourite books/stories for a while and you will notice that apart from the subject matter, the structure, as o
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
tlined above is always the same!
Follow the basic guidelines;
1. Think of a situation or problem that needs to be resolved.
2
Follow the basic guidelines;
1. Think of a situation or problem that needs to be resolved.
2
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
. Relate the methods/actions taken etc. to resolve the situation.
3. Solve the problem – everyone lives happily ever after!
Very few writers ca
3. Solve the problem – everyone lives happily ever after!
Very few writers ca
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
boast the ability to complete a short story/novel without some sort of structure, an often used example is:
1. A man gets stuck in a tree
2. T
1. A man gets stuck in a tree
2. T
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
row stones at him
3. Eventually get him down
Alternatively it could look something like this!
1. Your friend slips on some do
3. Eventually get him down
Alternatively it could look something like this!
1. Your friend slips on some do
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
g pooh, his false teeth fall to the ground, said dog runs off with teeth.
2. After recovering from fits of laughter you set off in pursuit of ma
2. After recovering from fits of laughter you set off in pursuit of ma
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
dog.
3. Promising never to tell a soul about the incident you eventually retrieve the teeth. Somehow you forget to tell him it was your
3. Promising never to tell a soul about the incident you eventually retrieve the teeth. Somehow you forget to tell him it was your
.
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
dog
Obviously there’s a lot more to it than this, but it really does help to start as you mean to go on. The formatio
Obviously there’s a lot more to it than this, but it really does help to start as you mean to go on. The formatio
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
of a structure for your story is essential, it may be nothing more complicated than the above example or possibly a far more elaborate blueprint
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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