Advice Pool - Health and Fitness

Discovering that your child is hearing impaired usually comes when you are the least ready for it. You already have your hand

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 full juggling a career, other kids, your spouse, and housekeeping. You can't imagine having another responsibility to deal

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ith.

If you work outside the home you may begin to wonder, "Will I have to quit my job?" If you have other young children wh

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

caring for them takes up a lot of your time, you may wonder how you will be able to give your child the time and energy that

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

is already in such short supply.

There is no easy answer to these issues. One thing is certain, just the fact that you are c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

onfronting these issues show that you are headed in the right direction. Realizing that your life must be focused on caring f

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

r your child's hearing impairment, is the first, and perhaps the most crucial step on the road to your child's ultimate succe

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

s.

Caring for your hearing impaired child does not mean you won't have a life. Although it is very difficult, and not many c

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

n do so, there are those who have successfully raised their hearing impaired children even while keeping their full-time jobs

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

. Lots of successful hearing impaired children were raised in families with other little children. If you have the determinat

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

on and the strength, you can do it all.

What is required, however, is a complete change of focus. You must always

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

eep your hearing impaired child's needs on the top of your priorities. All your other obligations must be secondary

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n importance.

Placing your child's needs above all is perhaps the toughest challenge. Once it is firmly established, everyth

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ing else will fall in place.

These are the 5 steps you must take to make this change of focus happen:

1. Realize That Your

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

hild's Success is Solely Dependent on You.

2. Your Child's Care is Your Number One Priority.

3. Enlist Help and Enc

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

uragement From Spouse and Other Family Members.

4. Educate Yourself on How You Can Work With Your Child.

5. Network

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

With Other Parents of Hearing Impaired Children.

Achieving this focus is very difficult, and it will take some time. Usually

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

this will require a dramatic change of lifestyle. Your family may also have to help out so that everything can work out.

Ul

.

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

imately, the hard work and sacrifices you and others make today will pay off. You will see the fruits of your labor with your

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

child's ultimate success. And by giving of yourself to your child, you will be making yourself a better person in the process

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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Advice Pool - Focusing on Your Child's Hearing Loss in Your (Already) Busy Life

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