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The race to be the Formula One king is heating up. Michael Schumacher of late has been closing the gap on defending champion Fernando Alonso.

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

This week the title race has reached Schumacher home turf at Hokenhien for German Grand Prix 2006.

Schumacher didn’t disappoint the home crow

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

Examples of combination products may in

d by securing the second place in the qualifying, well ahead of title contender Alonso who will start tomorrow’s race from seventh place on th

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

e grid.

Resurgence of Raikkonen

The Finnish driver so far has a disappointing 2006 after an ill lucked 2005 when his car failed him

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

time and time again. Today in Qualifying he and the McLaren -Mercedes team got their act together and secured pole position. This is ninth ca

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

Combination pro

eer pole position for the Finnish Driver and a welcome relief for engine provider Mercedes in its home grand prix.

Two Scarlets Tailing Be

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

hind

The two Ferraris of Michael Schumacher and Felipe Massa tailed behind Raikkonen and finished second and third respectively. This wil

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 provide an opportunity to Michael Schumacher to reduce the gap in title race.

Honda Heroics

The year started with much fanfare for

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

Honda as they materialize the Coup by signing Barrichello and some exciting times in the trials. Since then it has been a one way downstream

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

for Honda. German Qualifying raised hopes at Honda camp as both its driver finished in top six positions on the grid.

Alonso Hardship

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

Fernando Alonso will start from the furthest back in a race this year and have to drive out of his guts to secure something out of this race.

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

Following aspects would a

Above all his main concern will be to keep pace with Schumacher and prevent him from closing the gap in this year title race.

Qualifying r

dd to the challenges in developing combination products:

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

esult at Hockenheim:

1.Kimi Raikkonen (Fin) McLaren - Mercedes one minute 14.070 seconds

2. Michael Schumacher (Ger) Ferrari 1:14.205

3. Fe

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

lipe Massa (Brz) Ferrari 1:14.569

4. Jenson Button (GB) Honda 1:14.862

5. Giancarlo Fisichella (Ita) Renault 1:14.894

6. Rubens Barrichello

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

(Brz) Honda 1:14.934

7. Fernando Alonso (Spa) Renault 1:15.282

8. Ralf Schumacher (Ger) Toyota 1:15.923

9. Pedro de la Rosa (Spa) McLaren-

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

ercedes 1:15.936

10. David Coulthard (GB) RedBull-Ferrari 1:16.326

11. Mark Webber (Aus) Williams-Cosworth 1:15.094

12. Christian Klien (Au

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

Professional from academic institutions, pharmaceutical industries, health care indust

t) RedBull-Ferrari 1:15.141

13. Jarno Trulli (Ita) Toyota 1:15.150

14. Jacques Villeneuve (Can) BMW Sauber 1:15.329

15. Nico Rosberg (Ger)

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

Williams-Cosworth 1:15.380

16. Nick Heidfeld (Ger) BMW Sauber 1:15.397

17. Vitantonio Liuzzi (Ita) Toro Rosso-Cosworth 1:16.399

18. Christi

.

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

jan Albers (Ned) Midland-Toyota 1:17.093

19. Takuma Sato (Jpn) Super Aguri-Honda 1:17.185

20. Tiago Monteiro (Por) Midland-Toyota 1:17.836

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

Companies that provide selfless information through particip

21. Sakon Yamamoto (Jpn) Super Aguri-Honda 1:20.444

22. Scott Speed (US) Toro Rosso-Cosworth

( Source: Qualifying Table: BBC World Wide

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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