E-Articles - Health and Fitness

Presuming you have more than one child in the program, one of the things kids learn in Operation Pull Your Own Weight (OPYOW) is that every body is differen

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

t. And I do mean every body. Some bodies are tall while others are short. Some bodies are light while others are heavy. Some bodies are male, while others a

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

Examples of combination products may in

re female. Bodies even come in a multitude, a veritable rainbow of different colors, and each one is unique and different from the other, which is why the p

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

ull-up bar in this program is height adjustable…to accommodate all these different kinds of bodies.

Every Body Can Get Stronger

On the other hand, another

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

thing kids learn in OPYOW is that if you accommodate all these different kinds of bodies, every body can make regular progress towards the goal of being ab

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

Combination pro

e to Pull Your Own Weight, towards getting strong, and towards immunizing oneself against obesity for a lifetime. And when I say regular progress I mean tha

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

t…done right, every time a kid grabs onto the pull-up bar, he or she will be better, stronger, and closer to becoming immunized against obesity than the las

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

t time. And this predictable progress will continue for a good six to eight weeks.

Collective Success Is Built In

Done right, every kid learns to expect i

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

mprovement, every kid expects to be stronger, every kid expects that all the other kids will improve every time they have the opportunity to work out on 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

pull-up bar. And after each successful set of pull-ups, kids give each other high fives, and revel in one another’s success. Done right, this collective ex

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

ectation of success is built into Operation Pull Your Own Weight.

Regular Slices of Improvement = Winning

Another thing kids learn in OPYOW is that regula

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

Following aspects would a

r improvement is winning, and that winning is improving, getting stronger on a regular basis. They also learn that getting stronger on a regular basis requi

dd to the challenges in developing combination products:

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

res regular work, good eating habits, sufficient rest, and avoiding negative habits like tobacco, alcohol, and drugs. As a matter of fact they also learn th

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

e reverse, namely that without regular workouts, good eating habits, sufficient rest, and without avoiding tobacco, alcohol, and drugs, you are choosing to

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

be weak. And as we’ve said on previous occasions, NO KID WANTS TO BE WEAK!

Done Right, Every Body’s A Winner

When presented right, you have kids standing

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

n line at the annual fall fest, twelve and fifteen deep, all night long, paying money for the opportunity to get on the pull up bar and show their parents h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ow strong they’re becoming. You have fifty-out-of-fifty kids who actively choose pull-ups over recess. And in one case, you have an entire (at-risk) school

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

full of kids who take pride in their ability to Pull Their Own Weight. In other words, when presented right, in OPYOW, there are NO LOSERS, NO FAILURES. THE

.

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

RE ARE ONLY WINNERS. So make sure and present it right.

P.S. On the pull-up bar these lessons are learned in a very concrete (non-abstract, non-theoretical

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

Companies that provide selfless information through particip

) way. In other words it’s not just more talk, it’s real live, hands-on, interactive action that gets built into PYOW participants at a very practical level

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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Friendship influences individual's personality, perceptions and motivations of children, it influences moral and emotional development of children. Positive social experience and interaction with peers, friendship and comradeship are crucial for child's development and further socialization.

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