I Suggest - Cancer

With all we know now about the damage that the sun can cause, you may feel as though you need to hide under an umbrella all summer. And no wonder: E

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

xposure to the sun’s UVA radiation promotes irregular pigment, fine lines, wrinkles, rough texture, and thin and dry skin. UVB radiation burns as we

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

Examples of combination products may in

l as tans. And it can lead to skin cancer, of which there are a million new cases every year. But don’t fret: You can play outside safely. “Proper s

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

un protection will save your skin as well as your life,” says dermatologist Sandra Read, M.D. Try these sun-smart strategies:

Pick a nu

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

ber. “Anything less than SPF 15 isn’t worthwhile,” says Dr. Read. Go for an SPF of at least 30.

Choose wisely. Th

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

Combination pro

e SPF in your makeup may be fine when you’re spending most of the day at the office, but if you’re exercising outdoors or splashing in the pool, opt

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

for a waterproof sunscreen.

Read labels. Some skin savers: benzophenones (oxybenzone), sulisobenzone, zinc oxide, titanium

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

dioxide, and Parsol 1789. And last year, the FDA approved the UVA blocker ecamsule (brand name, Mexoryl).

Seek shade. Avo

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

d direct sun—especially between 10 A.M. and 4 P.M.—and wear a wide-brim hat.

Consider sun-protective clothing. A regular c

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

otton T-shirt offers an SPF of just 5, but tightly woven UV fabrics can block out more than 97 percent of UV rays. Also available, notes Dr. Read: R

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

t SunGuard, a clothing rinse with a special ingredient that effectively scatters UV light.

Don’t forget your lips and eyes.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
> Use lip balms and lipsticks that contain SPF, and choose sunglasses with UV-protective lenses.

About our expert: Sandra Read, M.D., is an in

dd to the challenges in developing combination products:

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

tructor in the dermatology department of Georgetown University in Washington, D.C.

Sparkling Beauty This summer, add some bling t

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

o your makeup routine. “The colors for this season are beautiful metallic shades,” says makeup artist Mally Roncal. To create your own luminous look

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

1. Keep foundation soft and sheer. “I love powder foundation in summer,” says Roncal. “It’s sheer and helps fight oil and shine.”

2. To help set

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

your eye shadow, start with eye shadow base. Then apply sheer metallic shadow from lash line to crease. Choose a liner with a bit of sparkle; dust w

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

Professional from academic institutions, pharmaceutical industries, health care indust

th translucent powder.

3. Apply blush to the apples of the cheeks in a circular motion, then swipe shimmery powder across cheekbones.

4. Slick on

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

lip gloss! Use a sheer “invisible” lip liner, or a natural liner that matches your lip tone, to keep gloss in place.

5. Polish nails to perfection

.

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

ith a cool, icy shade. “This summer, polishes are washes of shimmery pastel delight—think Italian ices,” says Robert Cleary, director of product dev

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

Companies that provide selfless information through particip

elopment for Dashing Diva. Follow these skincare- and makeup tips, and you’ll not only prevent skin cancer, but look and feel great all summer long

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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