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The history of ginkgo biloba is closely related to China, as this tree originates from this country. More precisely, gin

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

kgo biloba originates from two regions of China, which are named Guizhou and Anhui. Nowadays, exemplars of wild ginkgo b

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

Examples of combination products may in

loba trees can still be found in those regions.

In our times, this tree is regarded as a living fossil, because all the

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

other plants from its order existed 270 million years ago. The plants that are related to ginkgo biloba initially spread

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

across a wide area of Asia, but after a while, they became rarer. Ginkgo biloba seems to be the only survivor, fact that

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

Combination pro

sustains the fact that it is unique. Another fact that makes it unique is its longevity. According to some scientists, t

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

rees that have an age of 2500 and even 3000 years have been discovered in some regions of China.

People who have studie

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

the history of ginkgo biloba declared that some particularities of this plant permitted such longevity. The slow reprod

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

ction rate, the large distribution and the habitat of the ginkgo biloba tree helped this herb to preserve so good. As it

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

has been shown, this herb grew only on light soils, near the rivers. Later, people have been able to acclimatize it to o

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

her conditions.

Some people who analyzed the history of ginkgo biloba observed that this medicinal herb has been used b

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

Following aspects would a

oth in the Chinese traditional medicine and in the Chinese cuisine from a long time ago. While the Chinese cuisine makes

dd to the challenges in developing combination products:

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

use of the nuts and seeds of this tree, the Chinese traditional medicine uses the roots of ginkgo biloba. Later, in Euro

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

e, people started to use the leaves for producing supplements. As great amounts of leaves would be necessary to produce

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

remedy, people decided to use an extract from the leaves.

According to the history of ginkgo biloba, this herb has bee

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

used by the Chinese people for a long time in the treatment of several conditions. Although the active ingredients were

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

Professional from academic institutions, pharmaceutical industries, health care indust

not known in the past, this herb has always been regarded as a memory booster. In addition, the circulation of the bloo

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

throughout the entire body was also improved by using leaves or roots from the ginkgo biloba trees.

The Chinese doctor

.

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

that have used this medicinal herb in the past also knew that it is capable to treat certain sexual dysfunctions, such

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

Companies that provide selfless information through particip

s impotence. More recently, doctors determined that it is effective in the treatment of dementia and Alzheimer’s disease

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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