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Useful Advices - Plant The Culture Seed In The Right Place
Your company has, either by intention or by chance, created a culture. The culture is based
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
on your vision (or lack of a vision), your values (or lack of values), your mission (or lac
; 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
k of mission). You may have thought long and hard about your culture or it just might have
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
happened willy-nilly. Either way your customers understand your culture; your staff does al
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
so.
If your company’s culture has just happened by default, it is not too late to change, b
If your company’s culture has just happened by default, it is not too late to change, b
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ut if you want to change, please do it right. Some companies decide, all of a sudden as if
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
y a lightening bolt struck the building, “we need a company culture” and go out for pizza an
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
d a few beers to craft it. Lo and behold a company culture is born, written on a soggy napk
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in. Please do not do that.
A company culture is a delicate thing, in its early stages it i
A company culture is a delicate thing, in its early stages it i
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
akin to a young seedling growing in a field. At planting time, farmers and gardeners prepa
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
re the land. They remove the stubble left from last year’s crops, till the soil, then caref
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
ully plant the seeds, water and fertilize, then weed and nurture the plants as they germinat
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
and grow.
It is the same with the cycle of creating a new culture. The stubble of the old
It is the same with the cycle of creating a new culture. The stubble of the old
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
, used up culture has to be removed to allow the new one room to flourish and all the steps
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
need to be taken with care if it is to be planted in the minds of customers and staff. It 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
o must be carefully nurtured so it can grow and flower into a beautiful thing. You can’t pl
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
ant it in concrete; it must be planted with care and thought in the right place at the right
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
time. If all the steps are taken properly, the new culture will spring up and replace the
.
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
ld one and help bring bounty to those who took the time to carefully consider what they plan
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
t, how they plant it, and why they plant it, and what it is going to become when it grows up
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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