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There are over 40 fantastic golf courses on the Costa del Sol, Spain. Here is a story about one of them.

El Chaparral is a beautiful cours

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

e which is well manicured and according to most golfers they have some of the fastest greens on the Costa del Sol.

El Chaparral is an inte

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

Examples of combination products may in

resting course which has recently re opened after many years of becoming baron land. I believe there was an argument or misunderstanding be

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

tween the original owners but I am unsure of all the details. For over ten years the area had some fantastic houses with plenty of land to

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

walk their dogs.

Just over two years ago they started work on the course, re building, re laying the greens and tees, cutting the trees an

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

Combination pro

undergrowth.

El Chaparral has been open for over a year and enjoying great success with its layout, challenge and care of the course.

Th

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

e course is both beautiful and challenging and is made up of six par 3`s, six par 4`s, and six par 5`s.

The following is some general thou

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

ghts on some of El Chaparrel holes.

Hole 1 Par 4 319m is a great start with the fairway inclosed by the trees. It is not a long hol

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

e but its uphill and its important to keep the tee shot to the right.

Hole 6 Par 5 446m is nearly all downhill and played from the

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

right hand side the green can be reached in two. There is trees and water surrounding the green especially behind so be short not long.

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

Hole 8 Par 4 307m is a joy of a hole. You tee off up high and the hole swoops round to the right where nothing good will happen anywher

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

Following aspects would a

e to the right. If you tee off too long and don`t cut the corner of the dog leg you will find tree trouble.

Hole 9 Par 4 315m the

dd to the challenges in developing combination products:

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

last on the front nine where you are unable to see the green from the tee shot. Keep to the left and don`t go over the green as it is out

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

of bounds. Some great views of the Mediterranean running parallel with this hole

Hole 14 Par 3 155m can be longer than you think as

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

this part of the course can find some cross wind and the tricky green is well guarded by bunkers.

Hole 18 Par 3 162m the final hol

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

of the round is a simple shot over the gully on to the fairly thin green with everyone watching from the clubhouse. Hhhmmm

Not to worry t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he clubhouse is a beautiful building with great food for the hungry and a large terrace to really enjoy the 19th.

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

f="http://www.sungolfer.com/Costa_del_Sol/El_Chaparral.html">El Chaparral is a really enjoyable course, sometimes a little unforgi

.

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

ving and some holes are definitely target golf.

Also slightly strayed shots and balls can be lost.

If you wish to play this course then l

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

Companies that provide selfless information through particip

et Sungolfer help you.

Always enjoy your golf

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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