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Social Space - Cat in a Tree? What Goes Up Doesn't Necessarily Come Down!
Not long ago, our cat climbed the tall trees around our house and refused to come down.
We tried all the tricks:
We tried all the tricks:
- Opening a can of tuna and putting it at the base of the tree.
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
Nothing worked. She cried all day and all night.
It was piti
; 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
ul.
The first time she did this, I was traveling for the week. My wife called and said, "What do I do?"
"She got herself up there. She'll come down when she's ready," I said.
That advice
The first time she did this, I was traveling for the week. My wife called and said, "What do I do?"
"She got herself up there. She'll come down when she's ready," I said.
That advice
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
as filed in the "no-help" category. She called the volunteer fire department. They really didn't want to call out the boys to come drag the cat out of the tree either.
At the end of the sec
At the end of the sec
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nd day, I called her back and told her that according to resources on the web, cat's (almost) always come down between the third and fifth day when they get hungry enough.
"FIVE DAYS!?" cam
"FIVE DAYS!?" cam
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
roaring through the phone line. "I'm not waiting five days. She'll be dead!"
She was overreacting of course. The cat came down, hungry and tired, and extremely affectionate for an otherwis
She was overreacting of course. The cat came down, hungry and tired, and extremely affectionate for an otherwis
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
crabby cat.
"See," I said. "You just have to let nature take care of itself. We didn't have to worry about her. She knew how to solve her own problem."
Two weeks later, I was working from
"See," I said. "You just have to let nature take care of itself. We didn't have to worry about her. She knew how to solve her own problem."
Two weeks later, I was working from
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
home. The cat went up another tree - all the way to the top! All day, while my wife was at school teaching and I was home, tapping my computer at the kitchen table, while the cat cried outsi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e the window.
On the second day, I stood at the base of the tree and talked to the cat trying to coax her down. With her big eyes locked into mine, she talked back to me as if she were plea
On the second day, I stood at the base of the tree and talked to the cat trying to coax her down. With her big eyes locked into mine, she talked back to me as if she were plea
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
ing for help. After breakfast I put the little bit of yogurt that remained my bowl under the tree and clanged the spoon against the side of the dish. That sound always draws her.
She looked
She looked
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
at me crying even harder. If I could talk CAT, I'm sure she was saying, "Of course, I want that yogurt, you idiot. But do you see me - I'm 50 feet in the air in this huge tree!"
I was feeli
I was feeli
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
g pretty helpless.
After lunch, I dragged the 40-foot extension ladder to the tree and precariously positioned it on a slanting hillside so I could get a little higher in the tree. Then, do
After lunch, I dragged the 40-foot extension ladder to the tree and precariously positioned it on a slanting hillside so I could get a little higher in the tree. Then, do
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
ning a long sleeve shirt and leather gloves, up I went, one shaky step at a time.
The cat went higher.
I stepped on the top rung - right on the yellow sign warning me not to use the top ru
The cat went higher.
I stepped on the top rung - right on the yellow sign warning me not to use the top ru
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
g as a step - and climbed another 7 or 8 feet up the tree.
As I looked down, I realized I'm a 52-year old seditary man, 20 pounds overweight (on a good day) and about 50 feet off the ground
As I looked down, I realized I'm a 52-year old seditary man, 20 pounds overweight (on a good day) and about 50 feet off the ground
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
coaxing a scared cat to come a little closer so I can grab her - or worse - so she can grab me.
"This is a disaster in the making," I remember thinking.
Latching onto the cat by scruff of
"This is a disaster in the making," I remember thinking.
Latching onto the cat by scruff of
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
he neck, I held her at arm's length so that her horizontal paws, flailing at me like a small windmill with claws attached, couldn't get me. I shinnied down the big oak leaving deposits of 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
esh from my one arm wrapped tightly around the bark while peeling the cat off of every limb within paw-reach.
Slowly, and sweating off most of that 20 pounds, we made it to the ground.
Whe
Slowly, and sweating off most of that 20 pounds, we made it to the ground.
Whe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
my wife came home, she looked at the tree where the ladder still leaned and said, "Tell me you didn't climb that tree."
I confessed.
"I couldn't take it anymore. The cat needed our help a
I confessed.
"I couldn't take it anymore. The cat needed our help a
.
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
d somebody had to rescue her. She gets scared of something, runs up the tree and can't come down by herself."
She thought for moment, looked at me, and said, "That's Ryan, too, you know."
She thought for moment, looked at me, and said, "That's Ryan, too, you know."
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
y youngest son, scared for the moment, climbs a metaphorical tree and can't come down. So, for years I, or another member of his family, climbed up to rescue him.
I hate it when she's right
I hate it when she's right
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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