Advice Pool - Reference and Education

These days, when we hear the word abracadabra it will probably have just been uttered by a stage

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

musician. The word abracadabra, however, is very old and nobody knows for sure where or when it

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

Examples of combination products may in

originated.

The first known mention of the word was in a poem written by Serenus Sammonicus 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.

2nd Century AD. Serenus Sammonicus was the physician to the Roman Emperor Caracalla and the poem

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

was called De Medicina Praecepta, and in it Serenus prescribes the wearing an amulet around the

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

Combination pro

neck as a cure for sickness. The prescribed amulet consisted of a piece of parchment that had ab

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

acadabra written on it. The word was written several times with each repetition being situated b

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

elow its predecessor, and losing letters in each repetition, until only an ‘A’ remained of the w

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

rd. The resultant amulet took the form of a triangle and the idea was that the triangular format

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

ion of the magic word would act like a funnel and draw sickness out of the wearer’s body.

Abrac

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

dabra is actually a little more versatile than this though, and has also been used in amulet for

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

Following aspects would a

m as protection against evil spirits and the evil eye.

As to the origins of abracadabra, there

dd to the challenges in developing combination products:

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

re many theories about that too. Some people believe that it is Kabalistic in origin, perhaps de

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

rived from the Hebraic words Ab, Ben and ruach Cadesh (Father, Son and Holy Ghost). Other people

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

say that it comes from the Aramaic avra kehdabra (I will create as I speak). Still others say th

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

at it is Chaldean or that it hails from a Gnostic sect in Alexandria called the Basilidians. The

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

Professional from academic institutions, pharmaceutical industries, health care indust

e are, of course, other beliefs as well, but I think it is true to say that no one will ever kno

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

w for certain where the real roots of the word lie; they are buried too deep in history and have

.

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

grown obscure over the centuries. One thing is sure though: there is a lot more to abracadabra,

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

Companies that provide selfless information through particip

than just as a finishing line for the man on the stage with his magic wand and the deck of cards

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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