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Sit back and relax as I take you on a wondrous journey that transcends Russia, one third of the globe, from east to west.. Imagine sitting in a comfortable seat, looking out at t

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

he spectacular scenery and cities on your seven day journey.

I am talking about one of Russia’s most famous delights and adventures; the one week excursion on the Trans-Siberian

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

Examples of combination products may in

Railway from Moscow in the west to Vladivostok, of the Far East region of Russia. It is the longest continuous rail line on earth --almost ten thousand kilometers (about six thou

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

sand miles).

Traveling across the Russia on the Trans-Siberian train give you the opportunity to see with your own eyes everything that you might have heard about this mysteriou

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

s land of expansive forests, beautiful cities and the wilds of nature.

Your journey will allow you to see beautifully designed architectures of hundreds of churches; amazing sun

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

Combination pro

rises and even more spectacular sunsets. Your journey will allow you to view Russia in all her natural splendor as your adventure takes you through 7 time zones.

Your journey beg

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

ins when you board the train in the opulent and cavernous station of Moscow. During your adventure you will have many stopovers in almost 100 different cities both large and smal

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

l. The Trans-Siberian train stops several times a day, from just a few minutes to more than a half an hour. You will get the pleasure of interacting with simple Russians during

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

the short stop-overs. These Russian stations are often mini markets and you can see there everything from wild berries, farm sausages, delicious smoked fish to different souveni

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

rs and hats made from the fur of red, black, and white foxes.

You will have an opportunity to observe different architectural styles of the various towns and train stations. Most

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

of them were build during the middle of the last century of the Stalin era and at the end of the 19th century.

You will travel through one of Russia's oldest cities, called Yaro

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

Following aspects would a

slavl which was founded by Yaroslav the Wise in the year 1010. Another city, Yekaterinburg, was founded in 1721 by Catherine the Great. This is the city where Tsar Nicholas II an

dd to the challenges in developing combination products:

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

d his family were executed in 1918.

The experience will also propel you through numerous tunnels, some of them more than 2 km long. Feel and see the experience of riding in your

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

rail car on a bridge which is 2500 meters long over the deepest lake in the world, the Baikal which is said to hold one fifth of the world’s fresh water.

Along the way you will s

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

ee the biggest Siberian cities of Krasnoyarsk and Irkutsk , watching the vast Siberian taiga which is the largest remaining forest in the world.

The train will also stop in the

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

city of Ulan -Ude which house the Tibetan Buddhist monastery - the center of Buddhism in Russia.

Finally you will arrive in Vladivostok, the last city of Russia Far East.

Vlad

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

Professional from academic institutions, pharmaceutical industries, health care indust

ivostok is they gateway to Korea, China and Japan.

During the Soviet era, Vladivostok was a secret military base and was completely closed, not only to all foreigners but even t

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

o the citizens of all regions of the then, Soviet Union. You needed special permits just to visit relatives that lived in Vladivostok.

After 1992 this city was opened to all and

.

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

now anyone can see this beautiful sea port on the hills, named the " Russian San-Francisco” which is surrounded by the gorgeous Gold Horn Bay.

Although the Trans Siberian Railwa

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

Companies that provide selfless information through particip

y end in the sea port of Vladivostok, your journey does not need to end there. You could travel on to Russia’s eastern neighbors, Japan, Korea and China.

Have a wonderful journey

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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