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Many of us can judge the roll of a golf ball better than we can judge it

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

s flight.

If this is the case with you, perhaps you will choose to pitc

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

Examples of combination products may in

h the ball onto the edge of the green and let it roll up to the pin.

So

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

, which club should we use for such a stroke saving shot?

The rule is 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

hat the further we are from the edge of the green, the more a golf club

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

Combination pro

with loft is needed. This means that if you are say twenty five yards f

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

orm the edge of the green, you will use an eight or nine iron. Convers

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

ly, if you are four or five yards from the edge of the green, you will u

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

se a five or six iron.

Have you ever tried putting with a three iron.

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

This shot is for when the ball is two or three feet from the green, and

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

you have to go through some rough grass. Putting with a three iron seem

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

Following aspects would a

s to negate the effect of the grass and the ball is not slowed by it at

dd to the challenges in developing combination products:

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

all. It is like putting from that distance on the green.

Try using a th

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

ree or five wood from further off th e green. it the golf ball as though

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

you are putting from that distance and you will be very pleased with the

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

result. I save a lot of shots thaos way.

The idea of these shots is

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

Professional from academic institutions, pharmaceutical industries, health care indust

to hit the ball so that it lands on the beginning of the green and runs

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

up to the hole. The grip to use is one of three – some use the orthodox

.

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

grip, others use the putting grip, while others use the cross handed gr

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

Companies that provide selfless information through particip

ip where the left hand is placed below the right in right handed players

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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