References - Home and Family

For those that haven't heard of scrapbooking - where have you been? Scrapbooking is now a phenomenon and is spreading like wildfi

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

re through the craft world.

The term "scrapbooking" has been in existence since 1879 and refers to "the hobby of creating compila

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

Examples of combination products may in

tions in scrapbook albums, such as keepsakes, pictures, periodicals, articles, etc" (Dictionary.com). But the actual history of s

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

crapbooking itself becomes a little hazy once you start looking back through time. Although some historians claim it goes back to

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

Ancient Greece, most history books and websites quote the seventeenth and eighteenth centuries as the period in which scrapbookin

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

Combination pro

g was officially recognised.

A resurgence took place between 1880 and 1890 making it one of the most popular crafts of that perio

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

d. Scrapbooks lost their popularity in the 1940s but resurfaced again in the mid 1970s. It rapidly became a worldwide phenomenon

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

in the late 1990s and is now a multi-billion dollar industry even gaining a mention in the Wall Street Journal.

While the majori

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

ty of people involved in this craft are women, it was also a popular pastime for men. Thomas Jefferson, 3rd US President; Mark Tw

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

ain, author of "The Adventures of Huckleberry Finn"; Rutherford Hayes, 19th US President ; and Andy Warhol, pop culture icon, were

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

all ardent scrappers in their time. Thomas Jefferson kept volumes upon volumes of memorabilia, diary entries and clippings all o

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

Following aspects would a

f which can be viewed today. Mark Twain reserved the Holy Sunday to dedicate to his work and even patented a self pasting scrapbo

dd to the challenges in developing combination products:

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

ok in 1872. Rutherford Hayes was a collector of articles, photographs and incorporated details of his trips abroad into his scrap

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

books. Andy Warhol is well known for his compilation of 42 scrapbooks relating to his life and his work.

Kylie Rayner from All T

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

hings Scrapbooking says, "Scrapbooking is so much more than a hobby. It's the documentation of one's life and the preservation of

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

one's family history. Removing photos from old acidic albums or shoe boxes that are actually destroying the photographs within t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hem and placing them in a safe scrapbook album, will preserve the photographs for generations to come. The 'decoration' of each s

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

crapbook page ensures that the albums are viewed time and time again."

With the introduction of new computer software, scrapbooki

.

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

ng has now entered the electronic age and is showing no decline in its popularity.

If you have some spare time on your hands on y

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

Companies that provide selfless information through particip

our photo albums are in need of rescue, then now may be the ideal time to enrol in a class or visit your local scrapbooking store.

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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