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Social Space - This Too Shall Pass
Children have so many stages and phases that they go through. I'm not sure if it is to make us appreciate t
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
he wonderful moments more or just a cruel joke by God to speed up our aging process.
I do look forward to
I do look forward 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
the part of my day when my daughter gets home from school. I smile when I hear the bus go by, knowing in ab
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
out three minutes she'll be bounding in the door. I feel so fortunate that she shares her thoughts with me
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
at such a crucial time in her life.
"How was your day, honey," I say as I greet her at the door full of an
"How was your day, honey," I say as I greet her at the door full of an
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ticipation to share a special moment.
“It was really funny.”
“What?”
“When he did that.”
“Who?”
“Kyle.
“It was really funny.”
“What?”
“When he did that.”
“Who?”
“Kyle.
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
”
“Kyle who?”
“Kyle, in math class.”
“What did Kyle do in math?”
“He was so funny.”
I’m exhausted alre
“Kyle who?”
“Kyle, in math class.”
“What did Kyle do in math?”
“He was so funny.”
I’m exhausted alre
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
ady and my daughter has only been home from school for two minutes. I explain again like a broken record (p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
erhaps it is not sinking in because she doesn’t know what a record is) that she needs to start stories from
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
the beginning. I explain that if I wasn’t there, I don’t know what she is talking about.
It seems like su
It seems like su
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h an easy concept for an adult but it’s somehow it’s a skill lost on my 13 year old. So, I decide to better
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
explain myself. I’m an educated writer, I can do this.
I tell her that she needs to tell a story in chron
I tell her that she needs to tell a story in chron
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
ological order.
“What?”
I explain that she can set the stage, but needs to start from the beginning so I
“What?”
I explain that she can set the stage, but needs to start from the beginning so I
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
know what it is she's talking about.
“Why?”
So, I further elaborate that it is confusing to your audience
“Why?”
So, I further elaborate that it is confusing to your audience
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
if you just throw out the ending with no explanation. You need to let people know: who, what, where, why,
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
or when. It is just the way it is done.
“What are you talking about?”
“You’re story, about Kyle! And wha
“What are you talking about?”
“You’re story, about Kyle! And wha
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
t was funny about it?”
She looked at me like I made absolutely no sense. There was not even a spark of und
She looked at me like I made absolutely no sense. There was not even a spark of und
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
erstanding what I was talking about.
“I was only going to tell you that today in math Kyle fell asleep and
“I was only going to tell you that today in math Kyle fell asleep and
.
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
fell off of his chair.”
“Why didn’t you just say that from the beginning?”
“Geez, you never gave me a ch
“Why didn’t you just say that from the beginning?”
“Geez, you never gave me a ch
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
ance,” she said.
Here is where I cut my losses in an attempt to keep my sanity.
“Oh. Go do your homework.
Here is where I cut my losses in an attempt to keep my sanity.
“Oh. Go do your homework.
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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