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Advice Pool - It's Too Hard
A few evenings ago my son came to me very upset and said, "It's too hard!" My first thought was that something
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
really major had happened so my main object was to support him and help to resolve whatever the issue.
Come to
Come 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
find out he had put some projects off until the last minute (despite a few recommendations to break them down
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nto bite-size pieces) and was feeling overwhelmed. Bless his sweet heart...I had been there a few times myself
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
as a student so I understood the overwhelm. HOWEVER, not doing his homework was NOT an option.
At first I trie
At first I trie
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to encourage him but the more I tried the more upset he got. (Batten down the hatches, meltdown in 10 seconds
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
and counting.) Once again came the, "It's too hard!"
Rather than tell him that everything would be OK and that
Rather than tell him that everything would be OK and that
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
he could do it, I took a different tactic. I looked him in the eyes and said, "You know what, you're right...it
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
's too hard and I do not want you to do it." He looked at me as if I had grown a horn out the middle of my fore
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
ead. The rest of the conversation went somewhat as follows...
A: What?
Me: Nope, I do not want you to do
A: What?
Me: Nope, I do not want you to do
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
anything that is too hard.
A: What do you mean?
Me: Anytime you come up against something too hard, I
A: What do you mean?
Me: Anytime you come up against something too hard, I
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
do not want you to do it.
A:If I don't do things because they are too hard then I will probably wind up h
A:If I don't do things because they are too hard then I will probably wind up h
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
meless.
Me: Possibly, but just think, you will never have to do another hard thing in your life.
The end
Me: Possibly, but just think, you will never have to do another hard thing in your life.
The end
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
result, my adorable son went straight to his homework and finished it successfully.
My purpose in sharing thi
My purpose in sharing thi
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
story is to hopefully serve as a reminder to all of us. Yes, there are things in life that are hard, challenge
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
s will come that will suck big time, but here's the question...would you rather try or give up? You have everyt
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
ing to gain from trying and lots to lose by not trying. Think about it.
I encourage you (without fear of meltd
I encourage you (without fear of meltd
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
owns) to stretch and reach outside your box, embrace the challenges with an open heart, and have faith that fro
.
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
every challenge comes something good!
© 2006 – What’s Within U. All Rights Reserved. Reproduction of content
© 2006 – What’s Within U. All Rights Reserved. Reproduction of content
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
allowed, but must contain a link to What’s Within U (www.whatswithinu.com), copyright notice, and author’s name
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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