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Advice Pool - Do You Give Good Directions?
Do you remember learning to drive a standard shift vehicle for the first time? Did you pop the clutch out and it would stall?I remember trying to learn how to
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
drive a standard. Two years of one person after another trying to teach me how to gas, clutch and shift without stalling the car before I could at least hit 5m
; 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
h. It wasn’t pretty. After getting frustrated with one person, I would wait several months before I ran into someone else who would say, “I can teach you. Real
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
y, I can.”
The last person who ever tried to teach me was my cousin. We had always lived on opposite ends of the country, and I had just recently become acqua
The last person who ever tried to teach me was my cousin. We had always lived on opposite ends of the country, and I had just recently become acqua
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nted with her. We’d been hanging out for several months, getting to know one another when the conversation came up.
“I can teach you. Really, I can.”
I had h
“I can teach you. Really, I can.”
I had h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ard that before! But she followed it up with, “Everyone I have ever taught was driving around within 30 minutes.”
Well, that was a boast I could not let go. A
Well, that was a boast I could not let go. A
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
ter all, NO ONE had ever been able to teach me before. Boy, was she in for a surprise!
So, we went out to her car. She ushered me behind the wheel, got in the
So, we went out to her car. She ushered me behind the wheel, got in the
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
passenger seat, and instructed me to start the car. Easy enough so far.
“Push in the clutch.” Done.
“Put it in gear.” Done.
“Give it a little gas.” Okay.
“Push in the clutch.” Done.
“Put it in gear.” Done.
“Give it a little gas.” Okay.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Let out the clutch slowly.” Hey no one ever told me to do that before.
“When you feel it grab, freeze your foot on the clutch.” Hey! I could feel the gas/engi
“When you feel it grab, freeze your foot on the clutch.” Hey! I could feel the gas/engi
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
e/wheels start to grab a little.
“Now give it more gas till the car starts to roll.” I’m rolling. I’m rolling!
“Once the car has a good roll going, let the c
“Now give it more gas till the car starts to roll.” I’m rolling. I’m rolling!
“Once the car has a good roll going, let the c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
utch out the rest of the way.” Yippee! I have it moving!
“Unbelievable”, I had thought that day. I had never before gotten anything but a movement and a stall
“Unbelievable”, I had thought that day. I had never before gotten anything but a movement and a stall
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
But, you see, no one had every said anything to me except “Let out the clutch as you give it gas.” If you follow THOSE directions literally, you are bound and
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
destined to stall.
When giving directions, have you ever taken your directions for granted? Did you know them so well that you were unknowingly leaving some s
When giving directions, have you ever taken your directions for granted? Did you know them so well that you were unknowingly leaving some s
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
eps out? Or did you do it knowingly, because you didn’t want them to be too cumbersome or too insulting.
I once wrote a memo with step-by-step directions for
I once wrote a memo with step-by-step directions for
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
a computer task. This task was taught in a class conducted just that previous Friday. When the participants of the class had received that memo, they had looke
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
at it and threw their hands up in defeat. Their thoughts, “We just learned how to do this in only eight steps and now it’s twenty-five!”
For those who knew h
For those who knew 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
w to do it on Friday, it looked like I had invented steps. But they didn’t truly need those directions. I needed to include all the steps, because there were s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
me people out there who didn’t get it the first time around. I had to clarify every step. And after explaining this, those who complained about the extra cumbe
.
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
some directions, understood why it was needed. But more importantly, the others got it this time. Now everyone could do it.
So next time, try it your normal w
So next time, try it your normal w
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. And if they can’t “do it right”, step back and take a second look at your directions. Maybe a couple more details could make all the difference in the world
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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