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Okay, you have decided to learn how to hand spin. Wonderful choice! You have made the decision that you are going to invest in your very first spinning wheel. You have been look

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

ing all over that that perfect first wheel.

Now imagine that you have just entered a wonderfully quaint antique store and have your eye on this marvelous antique spinning wheel.

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

Examples of combination products may in

You move closer and touch this rich, wonderful, handcrafted spinning wheel. As you move your hand over the wheel you can see in your minds eye the many women that have stood in

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

front of a fireplace spinning at the end of the day. You put yourself in their place and can’t wait to take this wheel home! But wait!

Now you face a dilemma! What kind of wha

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

t kind of spinning wheel to buy. Should I get the antique spinning wheel I have just found or a new spinning wheel? What would be best for me? Here are some things to consider

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

Combination pro

hen choosing between an antique wheel and a new wheel.

Many of the antique spinning wheels have been stored in old attics, wet basements or have been housed in antique stores 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 don’t have adequate ventilation. Remember that the wood that was used to make this spinning wheel is now very old, and even though it was hopefully stored with loving care, it

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

still may have many problems associated with where it was stored as well as with its age.

If the wheel was stored in an attic, did the attic get too hot or too cold? This could

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

lead to problems with the swelling and shrinking of all of the wood in the wheel but most importantly with the moving wheel part itself. The heat and cold in the attic could caus

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

e the moving wheel to warp. Another consideration is that the actual moving part of the wheel could warp simply because of not being used or not being used properly.

Suppose thi

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

beautiful spinning wheel were stored in the basement for the last fifty or seventy-five years, there is a possibility that the legs and treadle of the wheel could have been subme

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

Following aspects would a

rsed in water at sometime. If this is true, then you might have possible wood rot in any part of the wheel that came into contact with the water over time. Basements are also not

dd to the challenges in developing combination products:

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

orious for being wet and damp which could lead to the wood swelling which could also damage your beautiful wheel.

If you have now decided that you cannot live without this histor

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

ically rich antique spinning wheel that you have just discovered, and believe me I would give my eye teeth for one, then consider using it as a focal point in your home. This bea

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

utiful wheel should be placed where all could see your investment but not where you would be tempted use it to spin. Please, please do not put your antique spinning wheel in front

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

of a picture window. I once drove by a house where a large, beautiful Great Wheel or Wool Wheel was displayed in the front picture window for all to see. It was a real thing of

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

Professional from academic institutions, pharmaceutical industries, health care indust

beauty, but I was also saddened because this beautiful wheel was taking daily abuse with the harsh sunlight and temperature change that it was being subjected to for years.

My ad

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

vice then is to purchase the antique spinning wheel if you want, but use it as a focal point. If you wish to spin on a wheel, purchase one of the new wheels that are on the marke

.

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

t. There are many beautiful wheels made today. Many companies still make the centuries old Saxony wheel or the Traveler Wheel that many spinners use today. There are even a fe

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

Companies that provide selfless information through particip

w craftsmen that are still handcrafting the Great Wheels or Wool Wheels as they did decades and centuries ago. The new wheel is most likely the one you want for daily spinning use

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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References - Antique Spinning Wheel or New Spinning Wheel, Which One Is Best For Me?

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