E-Articles - Health and Fitness

Because my hearing is somewhat impaired, I eagerly read “Save Your Hearing Now: The Revolutionary Program That Can Prevent and May Even Revers

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

e Hearing Loss” by Michael D. Seidman, M.D. and Marie Moneysmith.

Nearly half of 76 million baby boomers say they are dealing with some degr

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

Examples of combination products may in

e of hearing loss. That’s a 238 percent increase since 1990 when hearing problems affected only 20 percent of this group.

That means that if

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

you are at midlife or even younger, you need to read “Save Your Hearing Now.”

This unique book is more than just about how to save your

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

hearing. It is a comprehensive total health “how to.” Everything you need to know to protect your health and hearing, from exercise to

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

Combination pro

diet -- what’s new, what works, how to do it, where to get it – it’s is all there.

The amount of research that went into this w

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

rk to give the reader the absolute best information and help is outstanding. It’s a meticulous blueprint for achieving a better quality of li

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

fe.

Unlike other books on hearing loss that I have read, the authors provide a detailed one-of-a kind action program that will help you achieve a l

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

vel of overall vibrant good health and hearing you might not think possible. The program is a systematic, easy to follow, step-by-step plan that ma

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

kes it possible to successfully protect and improve health and hearing. If you now have hearing loss, you can learn how it may be possible to rever

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

e it. The authors explain how others have done it.

Because diet is key to health, and certain dietary supplements play a pivotal role in maintaini

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

Following aspects would a

g and repairing health and hearing, the authors tell not only what to take, but why you should take it and how much to take. This is critically imp

dd to the challenges in developing combination products:

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

ortant. Advice to take supplements is useless unless you are told how much to take and why.

I am particularly impressed that the authors stress th

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

importance and role of potent antioxidants in preventing hearing loss, particularly alpha lipoic acid and acetyl l-carnitine. Other major supplemen

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

ts scientifically shown to support good health and hearing are covered in detail.

You won’t be confused or overwhelmed with scientific jargon

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

because there isn’t any. Even if you know nothing about supplements, presentation of information is so clear and “user friendly”

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

Professional from academic institutions, pharmaceutical industries, health care indust

that you will “get it.”

The quality of resource material and supporting documentation reveals the ultimate usefulness and credibility o

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

any health book. “Save Your Hearing Now” provides many excellent resources with phone numbers, names and addresses for readers to use f

.

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

or additional help and guidance. As a pharmacist, I particularly appreciate the extensive documentation that supports the authors’ findings a

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

Companies that provide selfless information through particip

d recommendations.

Suggestion: If a midlife or younger friend has a birthday coming up, this is the most loving and life changing gift you can give

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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