E-Articles - Health and Fitness

In parts one and two of this series we covered how to document your goals and get a short list of good, qualified personal trainers. This final phase is a more personal one, where you get the opportunity to

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

talk with these trainers and find that perfect fit.

The 'Getting to Know You' Phase

In this phase you get to meet with your potential trainers, whether in a formal tria

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

Examples of combination products may in

exercise session (which may be either free or one you have to pay for), a 'get acquainted' talking only session, or even an e-mail or phone exchange to swap information about each other.

The first thing th

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

trainer should do is get a medical history for you and a list of your goals. Without this he/she has no way of determining the correct program for you. If they don't ask for these things and want to just

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

et started right away with your sessions, it's likely they don't have your best interests in mind. Either that or they haven't been properly trained themselves.

Your medical hist

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

Combination pro

ry

This is an extremely important step for the trainer to take. It will reveal if you are at risk for cardiovascular disease, and identify any other health challenges your program will need to acc

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

unt for. If anything out of the ordinary is identified, for example you display numerous risk factors for a heart attack, the trainer should request you receive medical clearance before participating in a t

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

aining program. If the trainer doesn't require a medical history don't hesitate to ask why.

Certified trainers are typically required to have CPR certification, but they would obviously prefer to help you

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

revent a heart attack instead of causing one for you.

Your List of Fitness Goals

This is an easy one. When your trainer-to-be wants to talk about your goals, just whip

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

ut the list you learned to create in part 1 of this series. They can then work off of that list and will probably probe deeper by asking additional questions in order to design the proper program. This is

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

lso a good time to include a list of question you have related to fitness.

This list of fitness goals should include a discussion on your preferred methods of exercise. The more you enjoy certain forms of

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

Following aspects would a

exercise, the more likely you will be to continue a program long term. A good trainer will want you to continue your fitness program long after your need for them has passed, so placing you in a program you

dd to the challenges in developing combination products:

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

enjoy is essential. A poor trainer is only interested in you if they can continue to make money off you by scheduling more training sessions. If they try to wedge you into a program that isn't right for yo

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

then they probably fall into the latter category, or they simply don't have the expertise to adapt the one program they know how to run. Many trainers will simply put you on the same program they use for t

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

emselves, and the majority of the time this isn't appropriate.

Decision Time

At this point you should have all the information you need to select a trainer. If you're s

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

re about your decision, you can often get a discount by purchasing multiple sessions up front. If you have any doubts, start off more slowly with fewer sessions because you can always purchase additional gr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ups of sessions when you become more comfortable. And be honest with the trainer that you want to make sure the fit between you and him/her is right before committing long term. A quality trainer will unde

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

stand and not apply unnecessary pressure.

Conclusion

I can actually condense the contents of this article in one simple statement. Do your homework. Act as if

.

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

you were hiring this person for a very important position in your company, because in a very real way you ARE hiring them. Personal training isn't usually cheap, and you want to make sure you get the most o

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

Companies that provide selfless information through particip

t of the money you're spending. Even more importantly you want to make sure your trainer doesn't put you in harm's way, which would be the opposite of your ultimate objective of being healthier and more fit

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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