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E-Articles - Do You Want To Stop A Bad Habit?
For the better part of 15 years I got in the shower every morning and wondered to myself if I drank too much. I smoked as 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
ell and knew it was terrible for me, but every morning I wondered whether I drank too much. After all, I drank virtually ev
; 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
ery day. As a matter of fact, when I tried to think of a day in which I didn't have a beer or three, I couldn't. And this
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
little ritual of asking myself the question if I drank too much went of for years. Then one day something interesting happe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ed.
I discovered that my 2 year old daughter was coming to live with Dad full time. I was very excited and intrigued by th
I discovered that my 2 year old daughter was coming to live with Dad full time. I was very excited and intrigued by th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e prospect of raising my little girl. It made me think though. Did I want her to be exposed to the practices of drinking 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
nd smoking? I mean she's young and probably wouldn't even realize what Dad was doing, right? And besides, it wasn't as if
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
were getting "falling down" drunk every night. I just liked to have a beer or twelve. After mulling these questions over
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
for a month or so, I came to my decision.
I wasn't going to be a bad influence on my daughter in any way. I couldn't be t
I wasn't going to be a bad influence on my daughter in any way. I couldn't be t
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
he guy that laments the dangers of smoking while I choked down a heater. Other guys can do what they want, but I simply was
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
't going to go along. And I wasn't going to be the guy that tells his daughter not to drink, while I drank a beer. No, not
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
me, I simply wasn't going to be that guy.
So, I walked away from both practices. No meetings, gum, patches, or pills. I
So, I walked away from both practices. No meetings, gum, patches, or pills. I
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
just walked away from a pack of cigarettes and an average of 6 or 8 beers a day. Through the process of doing this I realiz
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
ed a very important point. It wasn't about the fact that I smoked cigarettes or drank beer. It was about what I thought
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
about the two things. I realize this may sound strange, but it's true. What I realized was that what I thought about t
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 practices was the important thing.
In other words, if I thought quitting smoking was going to be difficult, guess what?
In other words, if I thought quitting smoking was going to be difficult, guess what?
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
It was going to be difficult. But if I thought it was going to be easy, guess what? The same principle holds true. The s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
me thing was true with drinking. If I thought not having a beer was going to suck, guess what? It sucked! But I also bega
.
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
n to realize that the opposite held true. It was all about what I thought! My bottom line is quite simple. If you have a
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
habit (that's what I believe these two practices are), and want to stop it, then change you thinking, it's as simple as that
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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