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Advice Pool - Article Writing - Using the Article Writing Master Mindset When Writing Your Articles Part 2
Article writing has a lot to do with expectations. And the article writing master minds
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
et has much to do with expectations.
The power of expectations
Years
The power of expectations
Years
; 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
and years ago I learned how to water-ski in Tallahassee, Florida. It was one of those
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
beautiful spring days. It was just warm enough to be in the water without being too co
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d but not hot enough to be uncomfortable, with not a cloud in the sky. You're on the w
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ater so you really don't realize you're getting fried by the sun. I discovered water-s
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
iing is a blast. I could not walk right for 10 days because I was so sunburned and wat
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
er-skiing uses muscles you never thought you had.
Fast forward about three years later
Fast forward about three years later
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
I hadn't water-skied for a couple of years. We went with a few people to the river o
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
r lake in town. Nobody else wanted to go first so I went first. I was waiting there i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the water for the boat to tighten the rope right there by the shore and I was thinking
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
to myself, "OK, you haven't done this for a couple of years. Just try to remember the
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
basics. You probably won't be able to get up. You will be able to get up but maybe by
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
the second or third time." And so the boat takes off. And I get up. I'm water-skiing
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
even though it has been two years. And then I fell. And as I'm floating there in the
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
ater waiting for the boat to come around I realized that I fell because I expected to f
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
all. I fell because I expected to fall.
So it has to do with expectation that has to
So it has to do with expectation that has to
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o with attitude.
I think there is such a thing as sitting down and writing, sitting do
I think there is such a thing as sitting down and writing, sitting do
.
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
wn and getting started block.
And that's the hard part.
So, whether for you it is sch
And that's the hard part.
So, whether for you it is sch
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
duling a time or just sitting down when the ideas hit, sit down and write your articles
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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