References - Recreation and Sports

Muromachi swords were called odachi or nodachi, and they were longer than 1 meter (they sometimes measured 120-150cm). These long katana swords, which sometimes

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

measure almost 2 meters were used for ceremonies only. After a short peaceful period, in the middle of this interval, the fight for power started again in 1467.

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

Examples of combination products may in

The whole country was involved in a constant war for over 100 years, when finally, Oda Nabunaga and Toyotomi Hideioshi succeeded to unify again and to set peace

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

in Japan. This period is known as Senkogu (the period during which the country was on war).

The swords in this period are divided in 3 specific historical grou

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: 1394-1466; 1467-1554 and 1555-1595.

During the first period (1394-1466), when armies grew too, as we have already said, the number of soldiers on horseback d

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

Combination pro

ecreased, which lead to an increasing of foot soldiers. Although tachi or odachi swords were still manufactured, the glorious period of katana swords was getti

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

ng closer. Shorter swords were more easily to wear and more easily to be taken out of the scabbard. The curve (Sori) of the these swords moved to the end, being

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

onceived to be used standing. Most of the swords had a length of 69,7-72,7 cm, and they got more narrow near the top of the sword. Towards the end of this period

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

, almost all the swords produced are called uchigatana.

During the second period (1467-1554), when the mobility of the troops became a strategic point, the swor

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

ds became shorter. Most of the swords manufactured during this period had a length of 60-65cm, and their width was almost equal to their length. This was the glo

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

y period of the katanas. This was a relatively short type of sword, which was worn attached to the belt, in the scabbard, with the cutting edge upwards. This fa

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

Following aspects would a

ct permitted to the sword to be taken out of the scabbard and the strike from a single move, whereas tachi was hanging at the belt, with the cutting edge downwar

dd to the challenges in developing combination products:

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

ds. In the same time, the necessity of a continuous source of swords, determined the fact that not all the swords manufactured during this period had the high st

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

andards to which they rose during previous periods. During this period Japan exported about 100 thousands of swords to China, which was ruled by the Ming dynast

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

at that time.

The end of the muromachi period (1555-1595) marked the total change of the way in which the wars were conducted in Japan, by the introducing of f

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

ire arms. In 1543 the Portuguese introduced the first fire arms in Japan. Even if the first arms of this kind were very good from the point of view of the accura

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

Professional from academic institutions, pharmaceutical industries, health care indust

cy, and they needed a long recharge period, Oda Nobunaga used them for the first time successfully during the battle of Nagashino in 1573. The horse back troops

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

f the Tadeka clan (being known during that period as an elite formation in Japan) were completely destroyed by a group of samurai, who were holding fire arms. Si

.

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

nce that moment, horse back troops were completely useless. The battle field was used then by small troops of foot soldiers, equipped with pistols. The armors be

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

Companies that provide selfless information through particip

came harder and thicker to protect the bullet holder, and the swords became once again longer, harder and more solid, in order to be able to penetrate the armors

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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