References - Recreation and Sports

The days are shorter, the air is colder and the streets are slicker. Yet, many will still brave the cold, damp and dark streets and trails

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

as winter sets in. For those who don't mind a little rain, snow, sleet or below freezing temperatures and run to survive the winter, it i

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

Examples of combination products may in

important to know how to protect the feet so they too, can survive the winter months.

1. Consider running in a trail shoe, even if you a

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

re not running on trails. Trail running shoes tend to protect your feet more than lighter nylon running shoes. Trail shoes also have mor

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

traction for slippery surfaces encountered during winter running.

2. Avoid cotton socks. Synthetic socks wick away moisture and help pre

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

Combination pro

ent blister formation and cold feet.

3. Make sure your shoes fit. Running shoes used for summer may not be an appropriate fit for winter. M

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

any individuals will experience a small amount of swelling in their feet during the summer. This may cause a loose fit for winter, leadi

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

g to heel slippage and potential blisters.

4. Pair your socks and shoes. Don't assume your heavier socks will work with your summer running

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

shoes. Some individuals wear heavier socks during the winter and this may lead to the toes being cramped in the front of the shoe causi

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

g discomfort, numbness and sometimes jamming of the toes leading to blood under the toenails. The reverse is also true. Your summer runnin

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

socks may not work with your winter or running shoes.

5. Avoid tight footwear in cold weather. Tight shoes may decrease circulation to t

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

Following aspects would a

he toes and increase the chance for nerve impingement on the top of the foot.

6. Run on flat surfaces. In cold weather it is more difficult

dd to the challenges in developing combination products:

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

to adjust to uneven terrain because your muscles do not react as quickly. This will increase your chances of developing muscle strains a

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

nd sprains. If you trail run in the winter, choose trails with fewer rocks, roots and dips.

7. Don't use your old worn-out shoes for winter

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

running. Do not start your winter running in shoes that have 400-500 miles on them. Wearing shoes that are worn-out can lead to foot pro

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

lems such as plantar fasciitis and tendonitis.

8. Warm up slowly. Your muscles will take longer to warm-up in colder weather. Your chances

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

Professional from academic institutions, pharmaceutical industries, health care indust

of injury increase when you do not take the time to warm-up properly.

9. Avoid speedwork in very cold weather. Speedwork in cold weather

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

ill increase your chances of injury. Consider saving speedwork for the warmer days, and use the colder days for maintenance runs.

10. Tak

.

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 a break from running. Consider cross training if you are feeling stiff and sore or if you are experiencing foot, ankle or leg discomfort

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

Companies that provide selfless information through particip

Overuse injuries occur more frequently in the winter as runners unconsciously alter their gait to adapt to slippery, hard to see surfaces

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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References - Winter Running: Survival Tips For Your Feet

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