E-Articles - Health and Fitness

Soccer is a very popular sport both locally and worldwide. References to the sport go as far back as 200 BC in China and around 4 BC in Greece. Howev

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

er, soccer as you and I know it did not have a formal set of rules set down until 1848 at Cambridge University.

Soccer is a very physically demanding

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

Examples of combination products may in

sport, thus making those who participate vulnerable to injury. The National Athletic Trainers Association (NATA) has done various studies on injury ra

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

es in high schools athletics, including soccer. It was found that most injuries in soccer occur to the ankles and feet, followed closely by the hip, 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

high and leg area. Common injuries include ligament sprains/tears, muscle strains, contusions (bruises), cartilage tears (more common in the knee) and

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

Combination pro

fractures. Higher percentages of injuries occur while kicking and when engaging in controlled pattern activity. Injury rates were higher at different

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

positions as well. Halfbacks had the highest rate of injury where the goalkeeper had the lowest. Interestingly, soccer was the only sport studied that

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

had more injuries during games than in practice. The statistics are very similar when comparing males and females in respect to the above information.

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

Head injuries are also of some concern. Studies by the NATA have shown that ball velocities can reach speeds up to 100km/hr (62 mph). However, most

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

situations in which a player will head the ball would be at speeds slower than 100km/hr. Average speed from a punt is 70km/hr (43 mph) and a drop kick

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

or goal kick 85 km/hr (53 mph). Most opportunities to head a ball are at velocities less than 65 km/hr (40 mph).

Where the ball strikes the head and

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

Following aspects would a

how the player strikes the ball are also of importance. Head-ball contacts that occur on the side of the head or the forehead of an unprepared player

dd to the challenges in developing combination products:

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

can lead to “whiplash” like injuries. It is recommended that contact be made at or near the hairline. Although the evidence is not conclusive that re

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

petitive head shots cause significant impairments in the long term, it is still worthy of precaution.

It is no secret that preventing injuries is pref

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

erred. With the higher demands on young athletes today, off-season training including weight training and general conditioning is an important step to

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

ards preventing in-season injuries. A 15 minute warm-up before practice and games and a brief cool-down period is also recommended. Rest and fluid bre

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

Professional from academic institutions, pharmaceutical industries, health care indust

aks are important as well. Protective gear such as mouthpieces and shin-guards can be very helpful. There are even various types of headgear that can

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

be worn to protect the head.

While we all get bumps and bruises, more serious injuries that involve high levels of pain, swelling and loss of functio

.

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

should be evaluated by your physician. Your physician may refer you to physical therapy for treatment. Your Excel physical therapist can guide you t

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

Companies that provide selfless information through particip

hrough a rehabilitation program to get you back on the playing field as quickly and safely as possible. Best of luck to all athletes this spring season

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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