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References - The Easter Hunt
"James. Psstt. Sleepy James, wake up," Lily whispered.
James was about to put his pillow over his head w
James was about to put his pillow over his head w
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
hen he remembered what today was. He sat straight up in bed. "Did he come?"
"I don't know. I was waiting
"I don't know. I was waiting
; 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
for you," Lily said.
James and Lily hurried down the stairs in their pajamas and opened the front door.
James and Lily hurried down the stairs in their pajamas and opened the front door.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
There were two empty baskets on the front porch.
"Oh, no!" said James, "No Easter Bunny."
"Wait," said
"Oh, no!" said James, "No Easter Bunny."
"Wait," said
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Lily. "There's a note."
Together, they read the note.
Dear James and Lily,
There are eggs and candy,
"Where's the first clue?" asked James. He turned the note over. "Here it is."
Clue #1
I wipe your feet
Together, they read the note.
Dear James and Lily,
There are eggs and candy,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
>
Chocolate bunnies, too,
but they are hidden away,
and can only be found by you.
Solve the r
but they are hidden away,
and can only be found by you.
Solve the r
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
iddles and you will find your Easter treats.
Love, The Easter Bunny
"It's a treasure hunt," said Lily.
Love, The Easter Bunny
"It's a treasure hunt," said Lily.
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
"Where's the first clue?" asked James. He turned the note over. "Here it is."
Clue #1
I wipe your feet
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
.
I keep dirt away.
Look under me.
Another clue will point the way.
"What does that mean?
I keep dirt away.
Look under me.
Another clue will point the way.
"What does that mean?
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
Lily said.
James looked down. "The welcome mat."
Lily lifted the mat. Taped underneath was the second
James looked down. "The welcome mat."
Lily lifted the mat. Taped underneath was the second
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
clue.
Clue #2
In the fall, I turn colors.
In the winter, I am bare.
Springtime is the best.
Clue #2
In the fall, I turn colors.
In the winter, I am bare.
Springtime is the best.
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
r>
I have new green to wear.
"A tree turns colors," said Lily.
They ran to the big tree beside the swi
"A tree turns colors," said Lily.
They ran to the big tree beside the swi
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
g set.
"There it is," said James.
Clue #3
I let you in,
I shut you out.
Sometimes you stand
"There it is," said James.
Clue #3
I let you in,
I shut you out.
Sometimes you stand
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
on me
and swing about.
"The door," said Lily.
"Wait. We can't swing on the door," said James.
The
and swing about.
"The door," said Lily.
"Wait. We can't swing on the door," said James.
The
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
thought and thought.
"The gate," James said.
They ran as fast as they could to the gate and there was
"The gate," James said.
They ran as fast as they could to the gate and there was
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
the next clue.
Clue #4
Your hunt is almost through.
You have one more thing to do.
Your treas
Clue #4
Your hunt is almost through.
You have one more thing to do.
Your treas
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
re is beside
Something shiny, red and new.
"My new bike," said Lily.
They ran back to the shed beh
Something shiny, red and new.
"My new bike," said Lily.
They ran back to the shed beh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ind the house and there, right beside Lily's new bike, were two baskets filled with Easter candy.
"This
"This
.
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
s the best Easter ever," said James, as he bit the ears off of his chocolate bunny.
"I hope the Easter B
"I hope the Easter B
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
unny does this again next year," said Lily.
"Me, too. Let's go show Mom and Dad what we got," said James
"Me, too. Let's go show Mom and Dad what we got," said James
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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