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The game of golf is played on a golf course, which is basically a large grassy landscape, consisting of lakes, trees, and small hilly m

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

ounds and is part of the way the game is played. A typical golf course has either nine-holes or eighteen holes.

To play the game, a pl

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

Examples of combination products may in

ayer would require golfing equipment such as playing clubs, shoes, tees, balls and a golf bag to store these items. The club is used 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.

hit the golf ball into successive holes located on the golf course.

Before a player hits the ball, he/she must stand with their feet

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

part and knees slightly bent. Holding the club firmly with both hands (placed one on top of the other), the player turn his/her body at

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

Combination pro

the waist along with the hip and back, thereby swinging the golf ball back and then forward. At the forward motion the ball is hit wit

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

h force and the player’s club is seen to continue to swing out. A low shot or a putt cover will cover short distances and is used when

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

the golf ball is quite close to the hole. In the case of a long shot, the ball moves very high in the air and travels a great distance

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

efore falling to the ground.

The game begins with the player placing a tee into the ground of the teeing area. A golf ball is placed o

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

n top of the tee and the player uses his or her club to swing and hit the ball. The objective here is to get the ball into the first ho

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

le on the golf course. After the first player’s shot, other players follow, with each attempting to put the ball into each hole around

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

Following aspects would a

the golf course.

As players progress through the game, they have to confront difficulties called “Hazards”. Water bodies such as small

dd to the challenges in developing combination products:

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

lakes, trees, shrubs, rough and sand-filled traps are all hazards, that the player has to get around, is the process of hitting a small

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

white golf ball into a sunken hole in the golf course. In a situation where the golf ball lands into a hazard, the player should not t

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

ouch the ground or water before playing the ball, even for a practice swing. If the player chooses not to play their golf ball in a haz

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

ard, the ball can be moved to the place from where it was originally shot, but a penalty stroke is added to the total score. Of course,

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

Professional from academic institutions, pharmaceutical industries, health care indust

with time and practice, many a player is known to become skilled and adept at the game.

A ball is considered to be lost when it cannot

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

be found within five minute of the shot. If the ball was hit by the player into an area that’s out of bounds or is lost, a penalty str

.

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

oke is added to the player’s score and the player has to replay his/her last shot.

In golf, scores are maintained by tracking the numb

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

Companies that provide selfless information through particip

er of times taken by a player to hit a ball into every hole of the golf course. The player with the lowest number of hits wins the game

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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