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The ways in which we treat humans are extremely different to the ways in which we treat an

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

imals. For example, we eat other animals, we wear certain animal fur and skin, we put anim

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

Examples of combination products may in

als down when we feel it is necessary, we test and experiment on animals for scientific us

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

, and the list goes on. However, it could be argued that these are not deliberate moral di

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

fferences, but a result of what is considered socially acceptable in Western contemporary

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

Combination pro

ociety. The thought of eating human flesh is regarded as 'disgusting', as is the thought o

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

f feeling sexually attracted to an animal. However, this may not be a moral concern, defin

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

ed by reason, but a reflection of social norms and values. Certain behaviour is socially a

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

cepted with in society because it is known as the norm, and the thought of eating other hu

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

man clashes with this norm, and therefore is rejected, but not necessarily because it is m

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

rally wrong. For example, other cultures with contrasting norms and values, such as certai

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

Following aspects would a

n native tribes, choose to include cannibalism within their lifestyle and do not view it t

dd to the challenges in developing combination products:

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

o be 'morally wrong' because it is socially accepted.

To treat a human being in the same

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

ay as one would an animal, would not be socially accepted. For example, in 1996 an article

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

was published in the Evening Standard telling the story of a "two-year-old boy who can on

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

y bark and whimper after being kept in a kennel with his parents' dog for most of his life

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

Professional from academic institutions, pharmaceutical industries, health care indust

". This is undoubtedly viewed to be 'morally wrong', however a large percentage of the cou

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

ntry treats their pets in this way without giving it a second thought. This point alone su

.

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

gests a very important moral difference between the way we treat human beings compared to

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

Companies that provide selfless information through particip

the way we treat other animals, emphasizing the different moral standards we place on both

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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