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Answers - A Structured Approach to Buying a Home - Part 1
For you, as a first time buyer, buying home is the most exciting enterprise. It is also the most important investment y
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
ou would be making for a long time to come – an investment which will dominate your life for the next 15 or 20 years. S
; 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
you should approach the enterprise with all the serious consideration it deserves.
From the point at which you start
From the point at which you start
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
seriously thinking of buying home to the point at which you move into your newly acquired home, the process of home buy
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ng can be broken down into five major phases. Each of these stages is vitally important for satisfactory conclusion of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
he enterprise.
• Formulating your concept of what you want; determine your needs;
• Budgeting and planning resou
• Formulating your concept of what you want; determine your needs;
• Budgeting and planning resou
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
rces
• Viewings
• Inspections
• Conveyancing: Making offer, Legal work
In the excitement of buying home
• Viewings
• Inspections
• Conveyancing: Making offer, Legal work
In the excitement of buying home
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
quite often a first time buyer tends to gloss over the primary step of formulating concept of what he wants. It sounds
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
so elementary to state what one wants – of course, one wants a nice house in a beautiful locality, which will be full o
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
f life but will give enough privacy for the small loving family ……
But is this your requirement or your dream? Think a
But is this your requirement or your dream? Think a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ain, think harder and separate your needs from your dreams.
After you have formulated your ideas of what you really wa
After you have formulated your ideas of what you really wa
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
t, comes the million dollar question – have I enough in my kitty to get me that “realistic” dream? How do I raise the m
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
oney? And how do I lighten the burden of loans, mortgages and interest payments?
Now that the two major questions are
Now that the two major questions are
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
ut of the way, its time for some leg work. You could start looking around for a suitable home. There are so many avenue
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
in which your hunt could go. Sit down and work methodically.
But while the exercise of viewings is on, don’t forget t
But while the exercise of viewings is on, don’t forget 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
hat you may want to make sure that your short listed properties are in good health. You may have to get professional in
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
pector to see that the property you buy does not become a millstone round your neck.
It’s time now to get your conveya
It’s time now to get your conveya
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
cing solicitor to start attending to the complex legalities of putting the deal through. With the painstaking thought p
.
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
rocess you have followed, it will not be long before you can plan to move into your “castle”.
It’s Champaign time now!
It’s Champaign time now!
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
We shall take a little closer look at each of the five stages of home buying mentioned above in the follow-up articles
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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