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Answers - The Home Office Commute
Like more people get to do every day, I work from my home office. As I look out my window on this cold, wet and quic
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
kly approaching snowy day, I’m reminded of how lucky I am. When I woke this morning I went through a similar routine
; 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
as most; I shaved and showered and dressed and prepped myself for the day. I ate a little breakfast and instead of g
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tting into my car for my morning commute, I strolled down the hall to my office arriving about five seconds later.
I
I
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
didn’t have to sit through traffic or get frustrated at the guy in the left lane doing twenty-five in a forty. I did
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n’t have to park out in the sticks hoping to avoid another door ding from the other guy stumbling into work and not p
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
ying attention to the world around him. I didn’t have to go outside in this miserably cold and wet day.
So now I si
So now I si
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
here with you sharing my thoughts and opinions. I expect that I have a more positive outlook than those who had to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ndure all of the above. However, it’s not always so rosey. ( I’m not sure if a pun was intended, but I do recognize
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
that it is punny, ha ha. ) Anyhow, when you work from home people don’t always think of you as working. I don’t kno
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
what it is exactly. I speculate that if they haven’t had the privilege of doing so themselves, I don’t think they f
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
lly understand.
Just because my commute is significantly shorter, doesn’t mean that I don’t have similar deadlines a
Just because my commute is significantly shorter, doesn’t mean that I don’t have similar deadlines a
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
d restrictions as they do. It just means that my commute is shorter. I have a double whammy because in addition to
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
working at home, I’m self-employed. So this must mean that I can drop everything at any time just because I want to.
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
This typically comes into play when the children have those “teacher workdays” or they’re sick. Speaking of teacher
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
workdays, I’m really tired of our educators complaining about how much they get paid. They have more time off... Any
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
ow. If I’m working at home, I must be the one who can watch kids. I’m here anyway. Think about if you brought your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
kids to your office. How productive would/could you be?
Just like most things in life, you have to take the bad wi
Just like most things in life, you have to take the bad wi
.
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
h the good. Don’t take me wrong, I’m not complaining. Not really. I have it pretty good. I’m just trying to enlig
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
ten those who don’t work from home to keep in mind that the most import word in “work from home” is “work” not “home.
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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