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E-Articles - There Are Always More Nos Than Yeses
Although it may not seem true, if we think about it, we will come to realize that there are always more nos than yeses. We will be turned d
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
own more often than not. The good news is that the more nos we get the more the yeses will increase. It is a numbers game. The more often w
; 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
ask the more our chances of success increase.
If, just for fun, we took a jar and put a penny in it for every no we received and took out
If, just for fun, we took a jar and put a penny in it for every no we received and took out
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a penny for every yes, we would never empty the jar. The nos will far exceed the yeses. There is of course one way to limit the number of n
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
os one receives, and that is to never ask. No comes from putting ourselves out there, being brave and taking risks. The good news is that 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
ing brave and taking risks usually doesn't call for any extra human capabilities. It could be as simple as asking someone out on a date or
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
pplying for a new job. A simple yes is easy, but most likely not. It is never easy to stretch our comfort zone and take the risk of being r
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
ejected. Thankfully, no one dies from rejection, and no simply means next opportunity.
In an interview with actress Christina Applegate, s
In an interview with actress Christina Applegate, s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e shares how being a teen star actually made it more difficult to break into adult acting. After ten years starring as Kelly Bundee on the
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
elevision sitcom "Married with Children," Applegate found it difficult to land adult acting parts. "You give everything you have and it's “
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o!. You hear no so many more times than yes.". Fortunately, Applegate did not give up, and ten years after her teen success, she has create
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
d a successful adult acting career. For Applegate, as with the rest of us, no doesn't mean stop, it means keep going. No is just one more h
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
rdle closer to yes.
Although hearing no and receiving rejection isn't easy, it is a part of life. We may never become totally comfortable
Although hearing no and receiving rejection isn't easy, it is a part of life. We may never become totally comfortable
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
ith rejection, and we can come to realize that no isn't a stopping point. No is a sign that a new opportunity is around the corner. No neve
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
r means the end unless we want it to. It means that we have to find a different way, look in a different direction, ask someone else, or as
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
in a different way. I received 47 nos when trying to find a publisher for my book. Had I stopped at any one of those nos, I would have mis
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
ed out on the 48th one that said yes.
No just means "next opportunity." Learn to take no in your stride and whatever you do - don't take i
No just means "next opportunity." Learn to take no in your stride and whatever you do - don't take i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t personally. When people say no, it doesn't mean anything about you, it is all about them. They may not be interested. They might not unde
.
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
stand the opportunity, or even what you are offering, or they simply may not be in a place to say yes. Whatever their reason, don't let it
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
ecome your excuse to stop. Find someone who does see the value, appreciates what you have to offer and has the ability and power to say yes
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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