E-Articles - Health and Fitness

• It’s too early to get up to exercise.

• It’s too dark and cold out to exercise.

• That treadmill is so boring.

• I don’t have time to take an a

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

erobics class.

• The gym is too expensive.

• I feel ridiculous trying to learn that hip-hop workout.

• It hurts too much to exercise.

• I am so

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

Examples of combination products may in

sore after exercising.

• I don’t have the energy to exercise.

• I hate to exercise.

The reasons people don’t enjoy a regular exercise routine are

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

many. It brings up bad feelings since they know there are plenty of important of benefits that they are missing out on. The body was meant to be

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

exercised and most people feel better when involved in physical activity. But that is not the case with the millions of people who are overwhelmed

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

Combination pro

with by thought of exercising.

One major hurdle is fitting an exercise program into a busy schedule. The basic recommendation is 30-45 minutes thr

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

ee times a week. More time is included in driving to the gym, getting changed, showering, etc. It can be particularly challenging when work and ot

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

er activities are already scheduled. A long workout, however, is not necessary to reap the benefits. Every walk across a parking lot, or up stairs

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

is useful to the body, even if the activity was done in short spurts. A few minutes of weight lifting while dinner is cooking will add up over the

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

course of a week of dinner making.

For others the problem is physical. Many people do not have enough energy to adequately perform exercise. A p

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

ainful condition or pain resulting from movement are serious deterrents to exercise. Atrophied muscles, poor nutrition, or a chronic health conditi

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

Following aspects would a

on may be the problem. Addressing these situations before proceeding with a very basic exercise program will help. A physician, chiropractor, phys

dd to the challenges in developing combination products:

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

ical therapist, and/or nutritionist can help monitor progress.

Not having established any good exercise habits while young makes it difficult, but

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

not impossible to overcome. Physical education programs and sports in school lay the foundation. Fitness ends up on the back burner when career an

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

family are priorities. But the practice can be restored at any age. Working out just because “you have to,” is not motivating. Working out in a

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

group with a common goal, however, can be emotionally gratifying. For someone who just doesn’t enjoy exercise it can become a dramatically differen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t experience when the focus is on some type of competition such as a walkathon, marathon or team sport. Preparing for the big day or building the

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

skills for competition makes exercise a challenge instead of a chore.

Whatever the reason for avoiding exercise, a solution can be sought out so

.

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

it becomes a comfortable and enjoyable activity. Seeking support from a health or fitness professional helps the goal seem more reachable. Getting

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

Companies that provide selfless information through particip

healthy is an important reason for exercising but feeling a sense of accomplishment for overcoming mental barriers can be a greater reward, as well

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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