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E-Articles - Be An Adovacte For Your Hearing Impaired Child
As every parent of a child with cochlear implants knows, their task is not an easy one. Juggling the responsib
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
ilities of the different appointments - therapy, mappings, evaluations, and IEPs, are overwhelming. Add to it
; 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
the hassle of dealing with the equipment - replacing broken parts, changing batteries, setting the proper prog
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
am; are a full time job in itself. All this leaves little time left over for anything else, let alone to focus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
on doing anything to improve the child's hearing and speech skills.
The evidence is clear - children who hav
The evidence is clear - children who hav
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e succeeded with their cochlear implants all had parents that were strong advocates for their child. The power
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
of a parent's advocacy and involvement cannot be underestimated. No professional - be it the child's speech th
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
erapist or their audiologist, can replace what a child learns from their mother. The professional should be vi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ewed only as a tool - to provide instruction and to evaluate the child's progress.
Parents may think that the
Parents may think that 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
r lack of professional knowledge stops them from being able to do much for their child.
This is absol
This is absol
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
utely untrue.
Chance upon any parent of a cochlear implanted child that is doing very well. You will
Chance upon any parent of a cochlear implanted child that is doing very well. You will
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
find that prior to their child's condition, they knew nothing about the subject. With the proper approach, th
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
y focused on becoming familiar with the topics, and utilizing their knowledge to secure proper care for their
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
child and to ensure that sufficient progress was being made.
For your child's sake - be involved. Learn somet
For your child's sake - be involved. Learn somet
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
hing new every day, and apply your knowledge properly. Know your rights when securing funding for your child's
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
services. Research online, join a membership, attend a conference, your knowledge and your attitude will chang
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
e dramatically. Your child's ultimate success will make it all worthwhile.
Cochlear Celebration 2007, held th
Cochlear Celebration 2007, held th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
is past February in San Antonio, was a conference for cochlear implant recipients and their families. The even
.
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
provided a great opportunity for parents to meet and draw inspiration from one another. Read more about this
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
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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