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Just Answers - Does It Summarize?
I go through an interesting writing exercise regularly: I take magazine articles and write abstracts of them for
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
a newsletter client.
The challenge involves taking an article, one that normally ranges from 1,000 to 3,000 wo
The challenge involves taking an article, one that normally ranges from 1,000 to 3,000 wo
; 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
rds, and condensing it into a few hundred words. That means I need to get the essence of the article squarely in
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
my sights and to write about it in my own words.
When I go through that exercise, I'm amazed at the number of
When I go through that exercise, I'm amazed at the number of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
articles, many from highly respected business magazines, that don't have internal integrity.
An article has int
An article has int
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ernal integrity when the writer started out with a central idea, developed it well, and reached a conclusion inv
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
olving that idea. For example, the writer might start with an anecdote, using the anecdote to illustrate a probl
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
em.
She then goes on to explain why this problem deserves our attention. That's followed by one or several pote
She then goes on to explain why this problem deserves our attention. That's followed by one or several pote
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ntial solutions, and the pros and cons of each one, along with a recommendation or two. She concludes the articl
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 by summarizing the problem, the alternative solutions, and her recommendation then links back to the opening a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ecdote. That's just one story development model, but one that works.
As I say, many articles don't have that ki
As I say, many articles don't have that ki
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
nd of integrity. Some miss one or more parts of the model, others get them in the wrong order, and some don't ha
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
ve a model at all, just the non-fiction equivalent of stream-of-consciousness (a fiction model).
You can ensure
You can ensure
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
your writing has internal integrity -- whether for memos, articles, instructions or anything else -- by taking
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
measures before or after your write. Perhaps the most familiar strategy is the preliminary outline. Before you s
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
tart writing, you set out the elements you'll address.
Another possibility is to go back to your message afterw
Another possibility is to go back to your message afterw
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
ard and write a short abstract, and ask yourself whether or not it makes sense. Does the story flow logically an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d clearly? Do you see any part of your model that might be missing?
A third possibility is just to set aside yo
A third possibility is just to set aside yo
.
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
ur writing for a few days, and then look at it later with fresh eyes.
Whichever you technique your choose, and
Whichever you technique your choose, and
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
that's mostly a matter of your personal style, your writing will get better results if it has internal integrity
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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