Advice Pool - Health and Fitness

Summer is just around the corner. Many of you have been cooped up in your home for the long winter. You and your body long to get out in the sunshine and enjoy t

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

he great outdoors. I do not blame you, and you should do just that.

For diabetics, especially those who do not have their blood sugar under control, this is als

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

Examples of combination products may in

a time for caution. Body extremities, especially the feet, need extra care and observation. In diabetics, circulation to the feet is often impaired. This situat

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

on is worse in long term diabetes and in those who do not have their blood sugar under control. Also, the nerves in this area are not always firing efficiently (

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

iabetic neuropathy).

The result of this is two-fold. First, since the nerves are not completely functional, the sensation or feeling in the feet can range from

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

Combination pro

ull to no feeling. So, sometimes small injuries go unnoticed. Second, impaired circulation makes it difficult for small injuries to heal once they happen. With t

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

ese two complications the once small injury, can become a larger wound without the person noticing. Infection could set in. and in the worst case scenario, gangr

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

ne could develop. My diabetic friends, I am not saying, don't go outdo

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

rs and enjoy yourself. Indeed, do go out and enjoy. It is god for you physically and mentally.

But, do take care of your feet! Check you feet on a daily basis.

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

here are many things to look for. These include any cuts, scrapes, bruises, splinters, stubbed toes, blisters, corns, callouses, ingrown toenails, sunburn, and w

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

o knows what else you could do to those marvelous feet. Check your feet daily. Cleanse your feet daily. If you notice any injury, no matter how small,treat it im

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

Following aspects would a

mediately. And if it worsens, go to your health care professional to get it cared for.

dd to the challenges in developing combination products:

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

Enjoy your summer. Wear well-fitting, comfortable footwear. Shoes that do not fit properly can cause blisters or scrapes. in fact, depending up

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

n upon the degree this disease has affected you, you may want to be fitted for those special shoes. The orthopedic shoes of today are not the orthopedic shoes of

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

yesteryear. Today, they make smart looking, stylish footwear for walking, running, jogging, hiking, the treadmill, and everyday wear.

In addition, you need to t

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

ke proper care of your toenails. If you are having problems with this, get a pedicure or see a podiatrist.

According to the American Diabetes Association, about

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

Professional from academic institutions, pharmaceutical industries, health care indust

15% of known diabetics will develop a foot ulcer in their lifetime. If not healed, this could lead to gangrene and possible amputation.

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

There are nutritional supplements which can aid in circulation. You can take vitamin E, Vitamin C, coenzymeQ10, alpha-lipoic acid, niacin and others.

.

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

But, do not do this in lieu of prescription medications. Check with your health care provider before starting a new nutrition regimen.

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

Companies that provide selfless information through particip

Keep on moving. Enjoy the great outdoors.laugh and play. But, do not forget to inspect and clean those wonderful feet that carry you everywhere

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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