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The fitness components for golf are a select few, but they are critical to a golfers success. The golf swing is a physically demanding movem

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

ent on the human body. It involves coordination, balance, stability, muscular strength and endurance, and dynamic sequence of motion just to name 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

few.

Do you think a body that is physically broken can accomplish a mechanically sound repeatable swing?

Based on the physical requirements of a m

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

chanically good golf swing…NO way! It is a physical impossibility to have a repeatable swing for 18 holes unless…you’ve implemented the fitness

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

omponents for golf within a consistent program.

When you isolate your golf swing muscles…stretch and strengthen them…and improve the efficiency

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

Combination pro

of sequencing your motions throughout the swing…you will no doubt be a massively improved golfer for the long term.

Isn’t that what you’re reall

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

y looking for?

I’m sure you don’t expect to be a single digit golfer if you’re currently a 20 handicap. But wouldn’t it be nice to shoot in th

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

low 80’s once in a while? How about consistently? It’s a reality if you take the fitness approach for golf.

For most of you in the U.S. it’s win

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

er time. There’s no better time than RIGHT NOW to start implementing 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

mponents-of-golf.html">fitness components for golf into your routine. You’ve got the extra time…and you DO want to play better next spring righ

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

?

Then get to it!

If I seem to be yelling…I AM! I really want you to listen to what I’m saying and apply it. Don’t be overwhelmed…I’m her

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

Following aspects would a

e in the flesh to help you in any way I can.

It’s my lifelong passion to educate golfers on the importance of the machine (body) in optimal golf pe

dd to the challenges in developing combination products:

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

formance.

Work on the “machine” and your game will skyrocket!

I played with a gentleman the other day that had every limitation in the book

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

And guess what? He could barely get the ball airborne. He was SO frustrated and embarrassed. I took him aside and gave him a little pep talk.

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

e only had a few holes left and I told him to RELAX and let his muscles do the work…with no thought at all.

I’m not kidding you…he parred the next

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

ole (his first par of the day). Bogeyed the next (but he was still happy). And parred the very last hole! It was like night and day.

He had SO m

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

Professional from academic institutions, pharmaceutical industries, health care indust

uch tension in his swing…he had no chance to created any torque and power. I gave him my card after the round…an low and behold…he went home and bo

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

ght ALL my golf fitness dvds AND my manual.

I personally called him and spent another 30 minutes on the phone with him.

He is now on his way to im

.

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

lementing the fitness components for golf into his “daily” life.

I tell you this story to give you hope!

Don’t give up!

It’s not

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

Companies that provide selfless information through particip

too late!

Hang in there and work on your machine. Trust me on this. It’s critical you pay attention to the fitness components for golf.

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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