E-Articles - Health and Fitness

‘A Golden Glow’, ‘Brown as a Berry’, and even ‘Sunkissed Goddess’ … all terms we want to have applied to us during the sundress season,

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

but we all know how bad the sun can actually be to our skin and the long-term damage it can do. So we slather on the sunscreen and assum

; 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 we are protected, right?Wrong! New studies reveal that not only are we applying our sunscreen incorrectly and too infrequently, but th

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

at it’s likely that the sunscreen we are using isn’t doing what it has promised.

Sunscreens should be applied at least one hour prior t

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

o sun exposure and should be reapplied every couple of hours and should be reapplied every time you get out of the water. But even befor

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

Combination pro

e you cover yourself head to toe, you need to do your homework.

More and more sunscreens are being brought to market with misleading an

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

d downright false labeling. Terms such as “sun block”, “water proof” and “all day protection” are commonly used on even the most popular

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

brands of over the counter sunscreens. None of these terms are accurate and are, at best, deceiving.

There is no “water proof” sunscre

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

en on the market today. A more accurate term to look for is “water resistant”. A sunscreen may be labeled “water resistant” by the FDA o

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

nly if it remains active for 40 minutes after exposure to water, but the best way to be sure you’re being protected is to reapply every

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

time you towel off. Even if you’re not in the water, sunscreens should be reapplied every two hours for maximum protection.

Absolutely

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

Following aspects would a

no sunscreen will “block” the sun’s harmful rays. Sunscreens can reduce your exposure to UV rays, but cannot block the rays totally. Usi

dd to the challenges in developing combination products:

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

ng a SPF 30 is a great start to minimizing sun damage, but there are more ways to protect your skin than relying on sunscreens. On a rec

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

ent trip to the beach, I was surprised at how many big brimmed hats I saw … tres chic and even more importantly … tres smart! Staying aw

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

ay from the water’s actual edge will lessen the reflective rays you may get and avoiding the sun altogether during prime burn hours when

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

the sun’s rays are the strongest (between 10AM and 4PM) will help save your skin.

One last thing … don’t be fooled into thinking you’r

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

Professional from academic institutions, pharmaceutical industries, health care indust

e better off heading for the tanning booth instead of the beach. The UV rays you receive in that process will damage your skin just as q

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

uickly as the real thing. Your best bet is to use a sunless self tanning product. And don’t forget that you are constantly exposed to th

.

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

e sun throughout your day, so using a sunscreen before you go out in the morning will help to protect you in the car, walking on concret

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

Companies that provide selfless information through particip

e, and lounging at your favorite al fresco bistro. Don’t be afraid of the sun, just be as smart about the sun as you are about your IRAs

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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