References - Recreation and Sports

Red hot favourites Brazil received a favourable draw as the group stage of the 2006 World Cup was announced on 9 December. The 16/5 favourites were drawn into Group F with Croatia, Australia and Japan. Hosts Germa

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

ny also has a relatively easy group with opposition provided in the form of Costa Rica, Poland and Ecuador.

However, not everyone was so lucky. Groups C and E have "group of death" credentials with Argentina, Ivo

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

Examples of combination products may in

y Coast, Serbia & Montenegro and Holland facing each other in the former, while Italy, Ghana, USA and the Czech Republic will battle it out in the latter.

GROUP A
Germany 7/1
Costa Rica 500/1
Polan

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

125/1
Ecuador 200/1

Germany should be able to qualify from Group A comfortably, kick-starting the tournament with a match against Costa Rica. Poland could prove to be tricky opponents and will be expected t

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

finish as runners up in the group. However, Ecuador may be capable of providing an upset as they beat Croatia in the group stages of the 2002 World Cup.

GROUP B
England 13/2
Paraguay 200/1
Trinid

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

Combination pro

d & Tobago 1500/1
Sweden 40/1

Second favourites England earned a favourable draw with two relatively weak opponents in Paraguay and first-time qualifiers Trinidad & Tobago. The final round of fixtures pits 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

em against Sweden who they have not beaten in 11 matches. The two European sides will qualify from this group.

GROUP C
Argentina 8/1
Ivory Coast 100/1
Serbia & Montenegro 125/1
Holland 14/1

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

tough group and one of two "Group of Deaths" in the opening stage of the tournament. Group favourites Argentina failed to qualify for the second round in 2002, finishing third behind Sweden and England but will b

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

expected to progress along with Holland. Both Serbia & Montenegro and the Ivory Coast will provide stern opposition and it would not be a surprise to see one of them qualify ahead of a perceived favourite.

GROUP

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

D
Mexico 50/1
Iran 500/1
Angola 500/1
Portugal 20/1

Top seed Mexico can be backed at larger odds than non-seeded Portugal but apart from who will finish first or second, this group should be

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

traight forward. Iran have won just once in six World Cup finals matches while first-timers Angola may find the step up difficult, despite finishing top of a tough qualifying group containing Nigeria and Zimbabwe.

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

Following aspects would a

GROUP E
Italy 11/1
Ghana 250/1
USA 100/1
Czech Republic 33/1

A very tough group to predict. Both Italy and world number two Czech Republic will be expected to qualify, although the USA, th

dd to the challenges in developing combination products:

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

mselves ranked eighth in the world, will also fancy their chances of progression. Ghana are one of the stronger African participants and are capable of causing an upset.

GROUP F
Brazil 16/5
Croatia 80/1

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

br> Australia 125/1
Japan 250/1

A favourable draw for Brazil who should qualify as comfortable winners of this group. Croatia failed to qualify for the second round in 2002 and may miss out again to Japan,

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

who topped their group four years ago at the expense of fancied European sides Belgium and Russia. Australia have the players capable of springing a few surprises but lack of experience at this level may go agains

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

them.

GROUP G
France 12/1
Switzerland 100/1
South Korea 250/1
Togo 350/1

France were heavily tipped to win the 2002 World Cup but finished bottom of their qualifying group failing to score

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

Professional from academic institutions, pharmaceutical industries, health care indust

single goal. There will be no excuses for not progressing from this group, arguably being draw against the weakest European opposition in Switzerland and the lowest ranked African nation in Togo. Despite a heroic

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

showing in 2002 which saw them reach the semi-finals, South Korea may struggle to qualify from this group.

GROUP H
Spain 14/1
Ukraine 50/1
Tunisia 300/1
Saudi Arabia 500/1

Under achieving Sp

.

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

in should qualify from this group, but may be pipped to top spot by the Ukraine, who stormed their qualifying group ahead of Turkey, Denmark and European Champions Greece. Despite a convincing qualifying campaign

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

Companies that provide selfless information through particip

hich saw them unbeaten and conceding only one goal in six games, Saudi Arabia will finish just short as will Tunisia, who have bowed out in the first round in each of their three appearances in 1978, 1998 and 2002

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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