Advice Pool - Health and Fitness

The penalty for having kids at a young age is that, before you know it, you’re a grandparent. My wife’s new title, “Granny” causes people to do a double take because, although sh

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 is no longer a spring chicken, she still looks like one.

This is due, in very large part to, as the grandkids say, “Granny pumps iron”! That makes me “Grandpa” and, of course,

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

Examples of combination products may in

I pump iron too.

We are doing well for folks in their fifties and early sixties but get this: We are in awe of Richard Sanders, of Decatur, Georgia, who, at age 97, pumps iron

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

twice a week at his local YMCA. “You get to be pushing 100 and things begin to change a bit”, said Sanders, interviewed in last week’s newspaper, “… this keeps my legs in better

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

shape … I have noticed a difference in my physical and mental well-being.” In addition to good genes, this gentleman has a great attitude.

Admittedly, Mr. Sanders uses very ligh

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

Combination pro

t hand weights and elastic tubing. That is more than enough to increase his strength and maintain his mobility when many men and women, twenty years his junior, are confined to 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

heelchairs.

The reason that he can get good results from light weights is that his muscles don’t know that they are light weights. All the muscles do is respond to a stimulus gr

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

eater than that to which they are accustomed. So, whether you are forty-five, eighty-five or anywhere in between, you don’t have to lift like a bodybuilder to get real results.

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

The choice of resistance is relative to the person doing the lifting. A forty five year old male, ex-athlete might handle twenty five pound dumbbells and progress to fifty pounds

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

and more. His seventy year old father may never lift anything over fifteen pounds (although many senior men do) and his eighty five year old aunt will probably get stronger by l

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

ifting two twelve-ounce cans of soup.

Taken to an extreme, consider that accident victims and invalids participate in strength and flexibility training. At this level it is call

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

Following aspects would a

ed physiotherapy, but it involves exactly the same principles.

As you age, especially if you are sedentary or have experienced a hospital stay, your strength declines until many

dd to the challenges in developing combination products:

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

seniors are incapacitated, not because of age but because of atrophy. For this reason, the importance of weight training becomes even greater as you age.

What “pumping iron” wil

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

l do for you at any age:

1. Improve strength and flexibility.

2. Shape and firm your muscles.

3. Make daily activities easier to perform.

4. Burn fat.

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

5. Improve blood chemistry.

6. Improve insulin sensitivity.

7. Lower blood pressure.

8. Reduce cancer risk.

9. Improve bone density.

Ladies who are afra

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

id of becoming “muscle bound” need not fear. Women lack the hormones necessary to develop large muscles. What you will experience however, is a fullness and shapeliness where yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u used to be flabby.

Senior men gradually lose the ability to gain serious muscle mass but, if they work hard, they can get significantly stronger and bigger well into their fift

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

ies and sixties.

The bottom line is that a weight lifting program can be tailored to persons of any age or ability. This activity is the single fastest way to increase strength

.

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

and mobility and change your appearance. An exercise routine that does not include weight training is incomplete.

Resistance training also imparts a deep sense of well-being. I

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

Companies that provide selfless information through particip

f you have never tried “pumping iron” consider doing so now. If you are older and want to hire a personal trainer, find one with a specialty certification in working with seniors

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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