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Business Dump - Essential Things
We all have them.
They are all over the house. We have them in the basement, in cluttered drawers, and in the garage.
Throughout
They are all over the house. We have them in the basement, in cluttered drawers, and in the garage.
Throughout
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
the years, I have accumulated an unbelievable assortment of tools. I honestly can open up a fix-it shop, right in my own home, if
; 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
wanted to chose this type of occupation.
For some reason when I go shopping, I end up buying another tool or a gadget, thinking th
For some reason when I go shopping, I end up buying another tool or a gadget, thinking th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t I might find a use for it. I have every kind of tool imaginable lying around in various place in my home.
I remember one day buy
I remember one day buy
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing a peg board for my tools. I have one in the basement and one in the garage. One afternoon, I spent an entire day organizing al
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
my tools, hanging them on my peg board. Stepping back, I admired my work and thought, "now I can find any tool I need."
I also ha
I also ha
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
e a collection of repair books. They too, are scattered all over the house. They are in boxes in the attic, the basement, and amon
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
g my cookbooks. Imagine that!
An insurmountable resource was literally at my fingertips. "I am woman." "I can do anything," I th
An insurmountable resource was literally at my fingertips. "I am woman." "I can do anything," I th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ught. I often get in this state of mind, when I become challenged, and have to depend on myself to fix something.
Then why do I c
Then why do I c
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
ntinually call a handyman?
I suppose, it is more convenient not having to devote three whole days just to fix a dripping faucet? A
I suppose, it is more convenient not having to devote three whole days just to fix a dripping faucet? A
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
so, my knees thank me when I place the call. On the other hand, I always beat myself up after writing the $250 check to the nice yo
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
ung man, thinking I could have done this myself.
One day my little bulb in my 37 year old oven burnt out. I decided to replace it
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
yself. "How hard can this be?" I thought. All I had to do was remove eight little screws, remove the backing plate, and put in the
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
new bulb.
So I began my task. I struggled for what seemed hours. I had more tools on the floor than God, while I attempted to ali
So I began my task. I struggled for what seemed hours. I had more tools on the floor than God, while I attempted to ali
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
gn the tiny screws into the holes, while at the same time, holding a small flashlight between my teeth!
Sitting on the floor, I con
Sitting on the floor, I con
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
emplated every move with care, feeling grateful that the oven door stayed down and did not slap me in the face. After much effort,
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
inally everything went in place.
Now came the test. I closed the oven door, switched on the light, and was amazed the light came o
Now came the test. I closed the oven door, switched on the light, and was amazed the light came o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n. I must have tested the switch a dozen times, unable to wipe the smile off my face.
John, the handyman called, asking "Is there
John, the handyman called, asking "Is there
.
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
nything you need done today?" "No," I replied, as I looked again at the light in my oven. "Well, you give me a call if something s
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
ould come up and you need me."
"If I lose my screwdriver, I'll give you a call," hearing John chuckle on the other end of the phone
"If I lose my screwdriver, I'll give you a call," hearing John chuckle on the other end of the phone
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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