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Useful Articles - Get Out Of Your Own Way
I don’t know about you, but I have a mind that loves to think. It seems to adore analyzing, figuring out, trying to come up with all of the details, the particulars, so it can come to a smart con
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
clusion. Untamed and unleashed, it goes all over the place, and I go crazy in hot pursuit.
Quieting my mind was an amazing accomplishment. First of all, I had no idea that I even had such a bus
Quieting my mind was an amazing accomplishment. First of all, I had no idea that I even had such a bus
; 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
mind... addicted to thinking and searching for data.
Learning to feel for my answers, instead of labor-intensive hard thinking, was a novel approach. What? No long, drawn-out internal planning
Learning to feel for my answers, instead of labor-intensive hard thinking, was a novel approach. What? No long, drawn-out internal planning
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sessions? No sorting or concocting? What’s a mind supposed to do?
Being “in feel”... you are so present and connected. The answer comes without the pushing, pulling, agonizing and effort. Bei
Being “in feel”... you are so present and connected. The answer comes without the pushing, pulling, agonizing and effort. Bei
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
g in the now, it is clear what to do next. But you do have to step aside and allow what wants to come through to present itself.
What if you had complete faith and confidence that everything woul
What if you had complete faith and confidence that everything woul
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
work out? What if your conviction and belief was so strong, that you knew everything would always be alright, even when on the surface it may not seem like it? What would your life look like wi
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
h unshakable faith? What then?
There is an issue of security and trust for me in wanting to cover all of my bases before I move. Funnily enough, when I am playing a game and I know that I am pl
There is an issue of security and trust for me in wanting to cover all of my bases before I move. Funnily enough, when I am playing a game and I know that I am pl
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
ying a game, I lighten up, I go with the flow, instinctively making the right moves. When it comes to life, a certain seriousness can creep in. I mean, I am an adult for heaven’s sake. Isn’t li
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e now supposed to be serious? This is serious business. You can’t just go with the flow? What if it’s the wrong move? What if you make the wrong choice? What if something bad happens? Hey, w
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
at if something good happens?
I get in my own way sometimes, because there is doubt, there is uncertainty and I am scrambling for enlightenment from an outside source. It may seem like there is
I get in my own way sometimes, because there is doubt, there is uncertainty and I am scrambling for enlightenment from an outside source. It may seem like there is
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n outside source, but there is not. You are it!
It is probably rare, that a child looks at a roller-coaster and wants blow by blow details to ensure their safety before they dare to get on the r
It is probably rare, that a child looks at a roller-coaster and wants blow by blow details to ensure their safety before they dare to get on the r
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
de. They look at it and anticipate the thrill, the challenge and the excitement. No hesitation. They jump on. It’s fun! They scream, laugh, scream some more and then they get on again... 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
gain!
What do we usually do as adults? We want every re-assurance that nothing bad is going to happen before we move. We want to know exactly what is going to transpire from the time we get on
What do we usually do as adults? We want every re-assurance that nothing bad is going to happen before we move. We want to know exactly what is going to transpire from the time we get on
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
ntil the time we get off. Even then, we may not trust what we are hearing and refuse to try something out.
Sometimes we create our own road-blocks. We create our own detours by getting in the w
Sometimes we create our own road-blocks. We create our own detours by getting in the w
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
y of what is ahead, of what is possible.
When I was little, I remember the feeling that I had when I woke up with the delightful realization, that it was the first day of my summer holidays. Una
When I was little, I remember the feeling that I had when I woke up with the delightful realization, that it was the first day of my summer holidays. Una
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
ulterated joy! Three glorious months spread out before me. I was in heaven! I woke up, eager to start each day. Oh, to explore and create my day just the way I want. What more could I ask for
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
I was home. No school. I had a huge yard to delight in, a forbidden open field next door, things to make, adventures to go on... Life was grand!
Do we wake up today to this same eager anticip
Do we wake up today to this same eager anticip
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tion? Do we wake up to this same feeling of adventure, the playfulness of creating our day’s story just the way we want? It certainly is within our grasp to do that. Do we reach out and grab th
.
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
opportunities, or are we hanging back, sheltered in the safety zone?
Step aside and allow your life to come through in all of it’s beauty. It will if you let it. Life naturally wants to spring
Step aside and allow your life to come through in all of it’s beauty. It will if you let it. Life naturally wants to spring
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
forth. It naturally wants to bubble over to amaze and delight you. Let it. I am always surprised and grateful at the ease , the effortlessness, the smooth flow of life when I allow it just to be
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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