References - Recreation and Sports

Golf is a game which is played with a club of various size. The interesting part of

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

the golf is that we don’t need a fixed shaped or standard area to play it. Golf pla

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

Examples of combination products may in

yground or 'Course' contains some 18 holes or 'Cup'.

'Tee', is a small sized peg to

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

support the ball to start a tee shot. The first shot is started with a tee to the g

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

een', the area where final cup is located'. In golf game, the ball is shot to comple

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

Combination pro

te 18 holes following a fixed order.

There are several rules for playing golf and 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

here are certain rules that tell how people can always avoid committing some mistake

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

and come up with read good game.

One must always pay heed to one of the most commo

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

n mistakes, that is called 'snap hook'. This is very common mistake. It happens when

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

a right handed person hits the ball and it curves sharply to the left direction. Th

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

s mistake can be easily recovered after a few practice sessions.

Another variation

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

Following aspects would a

of above mistake is called as 'Slice'. This mistake is most common for beginners.

A

dd to the challenges in developing combination products:

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

nother painful experience for beginners is called 'Blade'. It happens by hitting the

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

ball with the bottom edge of the club. This creates so much stinging feel in the ha

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

d. Even experienced players sometime are prone to this mistake. This mainly happens

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

due to lack of concentration and practice.

Another funny shot may be noticed when s

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

Professional from academic institutions, pharmaceutical industries, health care indust

omebody tries to hit the ball and completely misses it. It creates fun and yes, some

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

imes embarrassment too. This shot is called a 'Whiff'.

So next time when you are go

.

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

ing to hit the ball, just try to relax and concentrate more on ball rather than payi

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

Companies that provide selfless information through particip

ng much heed to lots of results in mind and surely you will produce positive results

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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References - Golf - How To Avoid Common Mistakes And Play It Like A Pro

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