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Useful Articles - A Question Of Choice
Having to make a choice or decision can prove to be one of the hardest problems which confronts us, especially when that choice or decision can be life-changing. So many factors have to be considered,
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
particularly if the decision involves making a career change. Such a change will often mean moving to an unknown area and possibly include finding suitable schools when families have to move. Many peo
; 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
le are afraid of change and miss opportunities which will never present themselves again.
Unfortunately, many people allow their fear of change to dominate their lives, so preventing them from achievin
Unfortunately, many people allow their fear of change to dominate their lives, so preventing them from achievin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lifelong ambitions. There are no guarantees that a particular life-changing decision will promise financial security and comfort but staying in the same well-worn rut will certainly not offer the pros
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
pect of a better life. It's a hard cold fact that success can only be measured after the decision has been taken and implemented. There is no way of knowing beforehand if the choice has been the corre
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t one.
When people are faced with a number of choices, the decision to make the right one becomes much more difficult, Should they, shouldn't they? Indecision grips them. Lots of people fear the unkn
When people are faced with a number of choices, the decision to make the right one becomes much more difficult, Should they, shouldn't they? Indecision grips them. Lots of people fear the unkn
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
wn and find it quite terrifying to even consider the prospect of making such a huge decision. What if it's the wrong one? How can they be sure? Even if the decision is right it may not lead to happin
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
ess. It is, however, far better to 'take the plunge' than stagnate in some stultifying situation.
One sure way to reduce the risks of making the wrong choice is to gain as much information as possible
One sure way to reduce the risks of making the wrong choice is to gain as much information as possible
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
before you make your decision. That probably sounds self evident but it's amazing how many people rush into ventures without checking all the details available. It's equivalent to buying a house witho
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
t having a full survey carried out on the property. It's too late once you've moved in to find the house is full of damp, has woodworm and dry rot to name but a few of the problems which can arise. Ha
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
a survey been carried out, you would have been in the position to make an informed choice about the property. In the same way, when faced with having to make a decision that will affect your life as w
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
ell as others around you, it is vital for you to make as many enquiries as possible. This will enable you to gain sufficient knowledge so that you can make an informed decision or at least help to infl
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
ence it, whatever the outcome.
If you've been unfortunate enough to make a wrong choice, it's not necessarily the end of the world. There's a lot of truth in the old adage, 'As one door closes another
If you've been unfortunate enough to make a wrong choice, it's not necessarily the end of the world. There's a lot of truth in the old adage, 'As one door closes another
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
door opens'. Many people have made a wrong decision but have found it has led to other opportunities for success which they would never have taken had it not been for the first wrong move. You will fi
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
nd there are often many options open to you but the problem lies in selecting the right one. When considering various options it's essential to look at the advantages and disadvantages of each one in o
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
der to minimise the risks involved. It will also make it easier for you to assess the consequences. Remember, however, that no matter how much you attempt to minimise the risks, there is no guarantee
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
nd never can be, that the decision you eventually make will be the right one. It is only hindsight that proves whether a decision is right or wrong and, as none of us can see into the future, we have t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o accept that life is not without risks. It must surely be better to live your life, with all its trials and tribulations as well as its successes, than to remain an onlooker for the whole of your life
.
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
afraid of your own shadow and forever looking over your shoulder. To be permanently gripped by indecision is no life at all. Not a single one of us knows what will happen tomorrow so why not make the
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
most of today? Remember-no guarantees - 'The best laid plans of mice and men often go awry'. In a nutshell there are so many 'unknowns' which we're unable to control, no matter how much we may want to
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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