Your Space - Health and Fitness

The crowd is on its feet wild with excitement. One basket and the championship trophy stays at home with your team. The basketball rebounds off the backboard directly into your daughter’s hands. There are scant seco

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

nds left to play in the last period of the game. She pivots quickly to takeoff up the court outpacing everyone; all of a sudden she pulls up grimacing in pain and grabbing the back of her leg. She falls to floor the

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

Examples of combination products may in

victim of a hamstring pull, possibly even a muscle tear, which could have been prevented - before time ran out!

Children are capable of placing themselves in all sorts of situations that demand good physical condit

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

ioning, especially flexibility. Running while playing soccer or baseball, high kicks in the martial arts, running the court in basketball, leaps in dance, and back walkovers in gymnastics all demand a wide range of

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

motion from the muscles involved, in other words flexibility.

Unfortunately, when an activity is so dynamic that it extends a body part beyond its normal range of motion, an injury may occur. Usually, the injury i

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

Combination pro

something minor like a muscle pull or strain, but it could also become a tear or a muscle separation from the bone on which it is anchored. To prevent such an injury all children should learn a basic flexibility p

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

rogram appropriate to their sport.

There are several aspects to flexibility (like joint specificity) that time and space will not allow for in this article, including some new thought on the subject that suggests

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

xtensive stretching before an activity is not as important as simply getting the blood flowing with some cardiovascular activity like jumping jacks. Stretching for flexibility then occurs after the workout for maxi

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

mum benefit. Consult with your coach for flexibility techniques appropriate to the sport your child enjoys.

However, as an example to help prevent hamstring pulls (muscle on the back of the upper leg) let’s evaluat

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

your child's flexibility in the lower back, hips, and the back of the upper legs. You can give your child this easy test.

Take a twelve-inch ruler and mark off one inch increments down the middle of a piece of pap

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

r. At the six-inch mark draw the number zero. Then, in one direction, mark the positive numbers +1, +2, + 3, etc. In the other direction, write the numbers -1, -2, -3, etc.

Have your child sit on the floor with

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

Following aspects would a

her legs extended. The back of her knees should remain flat on the floor with her toes pointing toward the ceiling. Place the scale marked with 1-inch units at her feet so the zero aligns with her heels. Every i

dd to the challenges in developing combination products:

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

ch mark towards the body is marked -1, -2, -3 and so on; each inch beyond the heels starting with +1, +2, +3 and so forth.

Now, have your child extend her arms out to her toes. Stop if it hurts, and by all means d

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

o not allow her to bounce or drive herself forcefully forward to get a better score! Only let her reach as far as possible without excess pain! If your child can just barely reach her toes, she would have a zero s

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

ore, which would be an average score. If she cannot touch her toes, she would receive a negative score of -1 or less. A child who shows good flexibility would have a positive score of +1 or greater.

Don't panic i

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 child can't touch her toes, but please don't ignore it. There are many solutions to this problem. Involving your child in physical activities at a young age that focus on all aspects of fitness, especially p

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

Professional from academic institutions, pharmaceutical industries, health care indust

roper conditioning and flexibility has benefits that will last into her adult life. Great activities that develop these components, especially flexibility are; gymnastics, martial arts, dance, and yoga. These are g

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

eat “gateway” activities that have advantages for other sports activities.

Pay attention while your child learns proper flexibility because some of the techniques for stretching hamstrings just might help relieve s

.

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

ome lower back pain for you too – but please check with you doctor or chiropractor first before stretching or attempting to re-live your childhood sports fantasies.

# # #

Notice: This article may be used in any pu

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

Companies that provide selfless information through particip

lication as long as it is used in its entirety without modification (minus this notice). When possible, include the copyright notice, web site URL, and email contact information on each printed or screen page online

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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