Advice Pool - Health and Fitness

Just a few short months ago I really believed Pilates was some sort of foreign idea, to me in the same ve

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

in as yoga, or ballet. In order to participate I thought I would have to be in a different frame of mind; I imagined heads

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

Examples of combination products may in

arves and coordinating outfits would be involved, right? Pilates exercises had to be a waste of time. Probably for older

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

, slower, maybe feminine types. I had always stayed fit. I played sports, shot hoops, jogged some, and never missed touch

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

ootball on the weekends with my buddies. If I hadn't been seriously injured, it would not have even occurred to me to try

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

Combination pro

balanced body Pilates. Why would I?

Then I was injured in a car accident. Luckily I was only bruised,

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

tiff and sore, but I found I was lacking in endurance and strength. That was unacceptable. I reluctantly tried balanced bo

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

dy Pilates on the advice of a friend of mine. She was struck by a cab three years ago and had significant injuries. She t

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

ld me that doing fitness Pilates classes had changed her life and insists she wouldn't be doing as well otherwise, which t

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

ranslated to me as saying she has had no long-term effects from her accident. I was dubiously impressed. My status quo was

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

not working and a hundred dollars was affordable. So off I went for my new outfit. (Seriously, a pair of sweats are fine.

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

Following aspects would a

)

I was surprised when during my research I found a few pilates studios in my neighborhood. But in my

dd to the challenges in developing combination products:

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

first visit I almost walked right out again. There were Pilates balance balls and all kinds of other silly-looking equipme

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

nt that seemed to have no place in an exercise class. I thought all of the people in the balanced body Pilates class were

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

housewives except for me. I felt out of my comfort zone. For lack of a better option I joined a local class.

F

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

ast forward: talk about eye-opening! Almost as soon as the balanced body pilates started, I felt cared about and

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

Professional from academic institutions, pharmaceutical industries, health care indust

felt better. The other members were helpful and caring; many shared their own stories of strength and endurance, immedia

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

tely shelving my limited opinions. The whole experience was engineered to help the body develop the proper postures and th

.

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

necessary strength and flexibility to restore my health. The balanced body Pilates led me to a full recovery. I experien

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

Companies that provide selfless information through particip

ced a total recovery of mind and spirit. This guy found his inner peace, his zone, and, I cannot recommend Pilates enough

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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