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To stretch or not to stretch…This is a question that has been posed by many people in their quest to eliminate repetitive strain

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

injuries like carpal tunnel syndrome, trigger finger, tunnel syndrome, cubital tunnel syndrome, guyon's syndrome, tendonitis and

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

Examples of combination products may in

many other upper extremity disorders.

The answer is yes, stretching in most cases is important in order to increase the length o

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

f tight, restrictive tissues. But there is a catch. Lets use the wrist and forearm as an example. If you stretch and lengthen one

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

side of the hand and forearm, say the front side, you need to strengthen and shorten the opposing side, or back of the hand and

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

Combination pro

forearm. If you just stretch one side and then do not perform exercises to the opposing muscle group, the tissues that were stret

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

ched go right back to where they were as there is nothing stopping them from returning back to their original position.

This is

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

where the strengthening exercises come in. By contracting and shortening the opposing muscle group, or back of hand and forearm,

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

the length created through stretching the front of the hand and forearm is maintained, keeping the muscles from returning to thei

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

r original position.

Stretching alone is NOT the answer. A well-rounded solution is to perform both stretches and exercises in o

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

rder to create balance around the joint. This is true with ANY and ALL joints. Be aware of the following when you implement a str

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

Following aspects would a

etching program:

• Perform stretches while in a properly aligned position.

• Don't strain or stretch too far-never stretch to t

dd to the challenges in developing combination products:

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

he point of pain.

• Increase the stretch only after you feel yourself / muscles relax.

• Breathe slowly while stretching.

• Do

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

not hold your breath while stretching.

• Do not overstretch beyond a point to where you feel pain.

• Hold each stretch for 15-

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

20 seconds to allow the muscle to relax.

• Repeat each stretch 2-3 times.

• Think about the area being stretched (Be in tune wi

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

th your body).

• If you feel pain ease off to a more comfortable position.

• If pain continues consult your doctor.

• Stretch

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

Professional from academic institutions, pharmaceutical industries, health care indust

within your limits.

• Your flexibility may vary daily so do not try to overdo it if your body says “no”.

• Adjust each stretch

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

to your own level of flexibility.

• Stretching is important to maintain flexibility so be sure to stretch as least 3-days per we

.

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

ek.

• Follow up exercises are important to maintain the effects of the stretch. Perform these exercises immediately to the oppos

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

Companies that provide selfless information through particip

ing muscle group(s) that was just stretched in order to maintain structural balance.

Stay Healthy - Your Health is in YOUR Hands

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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