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Summary - Sedona Method Questions
The most basic use of the Sedona method - and the easiest to pick up - i
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
s to ask yourself the three Sedona method questions.
B
B
; 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
fore we come on to these, you first need to identify a feeling or sensat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ion that is an issue for you. If this is the first time you've used the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
edona method, I suggest that you choose something fairly small. Just a n
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ggle. It could even be the feeling of doubt that you are currently exper
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
iencing over whether or not the Sedona method will work for you.
Once y
Once y
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
u've identified the feeling, ask yourself the three Sedona method questi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ons:
- Could I let it go?
- Would I let it go?
- When
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
Answer each in turn.
The fun part is that, so long as you
The fun part is that, so long as you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
on't sit on the fence, there are no right or wrong answers to these ques
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
tions. Questions 1 and 2 can be answered with either "yes" or "no". Ques
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
ion 3 can be answered with any time period, ranging from "now, this inst
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
ant" through to "never - hell will freeze over first" and all points inb
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
tween.
Then repeat the same questions until you reach a state where the
Then repeat the same questions until you reach a state where 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
feeling or problem no longer bothers you.
You may well find yourself la
You may well find yourself la
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
ughing out loud on the third or fourth repetition of the questions. That
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s great if that happens (but don't sweat if it doesn't). It means that y
.
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
ou are releasing your feelings and instead of them being pent up inside
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
ou, they are allowed to escape and stop irritating you.
Simple isn't it
Simple isn't it
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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