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E-Folder - Kindergarten Planning Works: And Works Extraordinarily Well - Auto Recovery
Have you ever returned to your office after time away to find where you left off and what priorities you are working had escape
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
d your memory?
I have. Too many times before I learned this...
Before I share the answer, come and experience my journey to
I have. Too many times before I learned this...
Before I share the answer, come and experience my journey to
; 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
he answer.
A year or so ago, I was returning after just taking Sunday off. That night, as I sat at home in my easy chair with
A year or so ago, I was returning after just taking Sunday off. That night, as I sat at home in my easy chair with
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 feet up and my review journal, I closed my eyes and remembered my day. Beginning from the time my feet hit the carpet to wh
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
re I was now. It wasn't a productive day and my critic was trying to justify it away with, "Its okay, nobody has a productive
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
day after coming back from vacation."
This was an eye opener for sure. I spent too much time fooling around with e-mails as I
This was an eye opener for sure. I spent too much time fooling around with e-mails as I
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
figured where I left off. During my review, I felt that lost feeling I was experiencing that morning that I kept pushing away.
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
A few days passed. Then another Monday and I began to experience this again. This time I knew it needed to STOP before I got
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
deeper into the day. "But how" I asked myself. I sat quiet and listened.
"Index cards" my mind answered.
"Index cards?" "O
"Index cards" my mind answered.
"Index cards?" "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
h, okay," my mind responded but just because there isn't something better coming up.
Kindergarten Planning Works: And Works E
Kindergarten Planning Works: And Works E
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
traordinarily Well
By Catherine Franz
I went into the supply cabinet and pulled out a stack of index cards. Back at my desk,
By Catherine Franz
I went into the supply cabinet and pulled out a stack of index cards. Back at my desk,
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
I sat staring at them. What’s next? "Shhh...quiet...listen!" So, I did.
"Write one project on each card." I obeyed.
"Okay
"Write one project on each card." I obeyed.
"Okay
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
what’s next?"
"Wow, you sure are impatient!"
"Yep, my parents complaint too."
"An hour or before you leave for a vacation,
"Wow, you sure are impatient!"
"Yep, my parents complaint too."
"An hour or before you leave for a vacation,
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
or even a weekend, write down where you left off and what was your next step," was the next message.
"Okay, gottcha. But...bu
"Okay, gottcha. But...bu
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
...but this seems so rudimentary. This feels like returning to kindergarten planning! I have all these other methods that do
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
his."
"Shut up; wear your Nike’s, just do it."
And so I did. To my surprise it works. It works darn well too. In fact, I h
"Shut up; wear your Nike’s, just do it."
And so I did. To my surprise it works. It works darn well too. In fact, I h
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
ve given this suggestion to many clients. Yes, they too rolled their eyes because it seems so ridiculously simple.
I went on
I went on
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to use this on a daily basis. Every night before I went home I updated my index cards. I crossed out the previous message, no
.
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
new cards until there wasn't any more room on the card, and wrote in the last thing I did on that project and the next step to
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
egin with tomorrow. To this day, I continue this process and my productivity is always high. Yours will be too when you begin
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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