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Answers - Creating a List Before You Go House Hunting
Nothing is worse than buying a home only to realize you don’t like it. Creating a checklist before you go hou
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
se hunting can help prevent this situation.
Creating a List Before You Go House Hunting
Finding the perfect
Creating a List Before You Go House Hunting
Finding the perfect
; 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
home can be both a grueling and incredibly euphoric task. It is a rare day indeed when the first home you loo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
at is the magic one. Instead, you are going to do a lot of driving and rolling of the eyes. As this process
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
continues, you can lose sight of the goal and get frustrated. The next thing you know, you own a home that ul
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
imately isn’t really what you were after. Welcome to the concept of buyer’s remorse.
What is buyer’s remorse
What is buyer’s remorse
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
It is a nightmare. It is sitting in a home you paid hundreds of thousands of dollars for and wondering what
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
you could have been thinking. Since turning around and selling it immediately probably does not make financia
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sense, you are stuck.
One way to beat buyer’s remorse is to focus on your goal. The first step to house hun
One way to beat buyer’s remorse is to focus on your goal. The first step to house hun
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
ing is not to go look at houses. It is to sit down and make a checklist. The checklist should include a wide
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ariety of things. On the positive side, it should include a list of things you like including particular home
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
styles, locations, layouts and those particular little things you want such as a workshop or whatever. Once
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
ou have the list of positives, you are half way there.
You should also create a negative section for your li
You should also create a negative section for your li
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
t. This should include elements that you absolutely do not want in the home you are going to buy. Items can i
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
nclude the location in relation to major roads, particular styles, layouts, yard size, garages and so on. The
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
point is to get everything you don’t want on the list.
Once you have a master list, you must stick to it. Di
Once you have a master list, you must stick to it. Di
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
cipline is the key. If you find a home that has everything, but is located one house from a high traffic road
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, don’t make an offer. Don’t be tempted! Stick to your checklist! If you find a great home in a bad area, mov
.
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
on.
Your list should be like a religious document to you. Stick to the guidelines you have put down and you
Your list should be like a religious document to you. Stick to the guidelines you have put down and you
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
stand a very good chance of avoiding buyer’s remorse. Stray from it and you have nobody to blame but yourself
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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