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Many players have learned how to successfully cheat at the game of poker. One such cheating method is mastering the

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

art of stacking the deck. To master this skill one has to be good with sleight of hand. This is done by a special wa

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

Examples of combination products may in

of holding the deck of cards that allows the deck to be manipulated, or stacked, one of these special ways is calle

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

d the Mechanic’s Grip.

To help you better understand this cheat, pick up a deck of cards as if you were getting rea

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

y to deal. You will probably be holding the deck in the palm of your hand, with your thumb on top of the cards, and

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

Combination pro

your other four fingers on the side of the deck. When dealing cards, you use your thumb to push one card onto the ti

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

s of your other four fingers. The thumb is then used to hold this card in place, until your thumb and pointer finger

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

of the opposite hand grabs it and deals the card out. Many poker players deal this way, even though they probably h

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

ve not noticed it or put much thought into it.

To form the Mechanic’s Grip, move your pointer finger and middle fin

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

gers to the short side of the deck, farthest away from yourself. With this grip, more of the deck is covered by your

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

hand, making it harder for the other players to see what you are doing. This grip is the basis for many cheats, such

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

Following aspects would a

as peeking (the dealer will either push one corner, or side of the top card, away from the rest of the deck so that

dd to the challenges in developing combination products:

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

he can see the top card), bottom dealing (dealing the from the bottom of the deck instead of the top), and second de

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

ling (dealing the second card in the deck instead of the top card, usually when the dealer wants the top card for hi

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

s own hand). By using the peek, the dealer will be able to keep track of what cards each player gets, he can also se

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

up his own hand by combining the peek with second dealing. Knowing what cards the other player has in his hand gives

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

Professional from academic institutions, pharmaceutical industries, health care indust

the dealer an advantage when playing his own hand, because he will know what cards he needs to beat the hands of th

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

other players.

In another version of the Mechanic’s Grip, the deck is held with the thumb on the top, the pointer

.

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

finger around the front edge, the pinky around the back edge, and the two middle fingers under the bottom of the dec

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

Companies that provide selfless information through particip

.

Using this cheat can be very effective for the dealer, as it can definitely help him stack the cards in his favor

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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