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Useful Advices - The Area Where To Look For When There is a Problem
There is a problem. Nothing unusual but these things happen in every organization. In any sit
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
uation; from chipping come chips? What is important is how you solve problems. “Each case is u
; 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
nique,” that is one answer. But when added all (cases) up; where would you look first? Or what
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
do you think when you look at your organization. What is the area where normally the problem
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
arises? And. "Couldn't we have prevented this?"
This is a question without an answer. In fact
This is a question without an answer. In fact
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it is true every situation is unique. But maybe you should check for yourself; what is the fi
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
rst "place" where you would look for. There are four options.
There is no business without a
There is no business without a
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
system these days, so the first natural place to look for would be any such a system. Any comp
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
uter system, methodology that is not followed in the right sense, or any equipment that deviat
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
es because of this unique situation.
No, someone else tells me, most problems have nothing to
No, someone else tells me, most problems have nothing to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
do with a system as such. Not what is invisible and behind the black box. What is increasingl
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
y the issue, is the fact that we depend more and more on others. We face problems with interfa
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
ces and dependencies with other departments, companies, partners or suppliers. XML didn’t help
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
us either.
Both are true, but there is a third area in which you will find most problems. Pr
Both are true, but there is a third area in which you will find most problems. Pr
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
oblem area #1; infrastructure. It is the glue that binds all together. The quality we sometime
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
s forget but what spoils the party right when you do not expect it. "Seven out of ten it is 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
frastructure."
The last option is closest to the truth. Heavenly underestimated. But probably
The last option is closest to the truth. Heavenly underestimated. But probably
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
most problems are due to human miscommunication. The area of interpersonal relations. We talk
.
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
, we discuss, we present, we tease and we try to convince. But never enough.
A simple rule; b
A simple rule; b
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
efore you think you are all set and ready to go, check again and communicate.
© 2006 Hans Boo
© 2006 Hans Boo
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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