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According to the 6,268 attendees that had been questioned about their objective why they need to work, 99 percent answered; “they need to work to earn a living and bridge th

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 gap of their growing financial capability.” The worker should get a job to earn a living. In addition, as they work, they should be paid accordingly.

Let us try to look o

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

Examples of combination products may in

the idea closer, a student’s objective is to finish his/her studies. To achieve this, he/she should study hard, and the details of studying hard are: (1) should be always p

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

resent in class, (2) participate in the class discussions and group works, and (3) do the homework, projects and other requirement for the course. The range of the objective

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

of the student focuses merely on the course.

On the other hand, to achieve the worker’s objective he/she should: (1) follow the company rules and regulations (CRR). Every w

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

Combination pro

rker follows the CRR. The range of objective focuses only on the worker’s personal satisfaction. He/she gives only a bit of his thought on the company/factory where he/she g

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

ets the source of living.

Let’s try to imagine this analogous situation. There is a lake in a nearby village near a mountain where different species of fish abound. This la

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

e produces enough fish for the villagers. As time passes by, the village grew doubling its population. The lake that had been producing fish for every table became source of

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

recreation and playing grounds for the youngsters.

During the early stage of civilization, the father was the one responsible for the food of his family. The head of the fa

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

mily as breadwinners noticed that they were catching lesser and lesser fish from the lake. They became aware of the help the lake was extending to them. And so, an assembly

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

as called, every member of the village young and old were required to attend. The leader discussed some problems, as earlier reported to him, on how to preserved the lake so

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

Following aspects would a

as to produce again abundant fish for the increasing population. Policies, rules and regulations and some precautionary measures were introduced. The leader emphasized the i

dd to the challenges in developing combination products:

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

mportance of the lake as source of living. It was then agreed upon that these rules and regulations should be strictly observed, that who ever violates would be punished, an

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

be exiled from the village if the degree of destruction created is severe. For just a short time, the lake was revived. But due to unavoidable circumstances, the villagers

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

ontinue to cut trees from the mountain forest for their fuel, shelter or just to clean the land for their agricultural crops. The trees were no longer enough to hold the wat

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

ershed, and the mountain was almost denuded. What do you think will occur if the mountains will be denuded? For just a few years, the lake that had been supplying fish for t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e villagers was gone.

Let us apply this scenario to the present situation. On the diagram, the workers source of living is the company. Every worker is required to follow t

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

e rules and regulations implemented by the company. But the behavior extended by the workers on how to follow the CRR differs from each other. On the part of he worker, they

.

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

are following these CRR because it requires them to do so, so as to meet the quota. Not to mention that their minds are set that as they work they should be paid accordingl

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

Companies that provide selfless information through particip

. And majority of the workers are not aware that a single mistake could ruin the entire production, that the only way to avoid such mistakes is for them to work harmoniously

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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