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Some little fish are more dangerous to divers and swimmers than sharks.

Some tiny, harmless lo

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

oking creatures at the sea are more hazardous than big, ugly looking ones.

One type of these b

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

Examples of combination products may in

eautiful but poisonous fish are called the Lion-fish. Being of the Scorpion fish family, this

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

brightly colored fish is usually found in coral reefs at the red sea.

Lion-fish’s danger is th

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

e poison it holds under the skin near by each of its 13 spines. It uses the spines to subdue i

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

Combination pro

ts enemies. Anyone touching the spines will feel a deep sharp pain and the effected area will

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

swallow and infect rapidly.

Some swimmers and divers may think they can hold these beautiful c

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

reatures in hand but that is not recommended.

By holding the creature in hand you trigger its

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

self-defense mechanism. This type of fish moves quite slowly in the waters and it is a very ea

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

sy catch for hunters. This seems to be the reason for developing such lethal and painful self-

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

efense system.

It is said that the wound caused by Lion-fish lasts about 30 hours. The sting c

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

Following aspects would a

auses nausea, paralysis, convulsions, and even collapse. Victims have also reported breathing

dd to the challenges in developing combination products:

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

difficulties.

Despite believes that this type of fish only attacks in self-defence, some incid

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

ents of uncalled for attacks on humans have been recorded occasionally. Obviously, just like m

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

any other fish, Lionfish normally attacks when it feels it is in danger.

Most attacks on swimm

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

ers and divers by Lionfish have been seen in the gulf of Aqba, while in other areas this fish h

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

Professional from academic institutions, pharmaceutical industries, health care indust

as shown mostly a peaceful nature.

Suggested treatment of someone bit by Lionfish includes sub

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

merging the effect body area into some hot water. This will help the blood flow and consequent

.

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

ly disperse the venom. Aesthetic agents locally administered can provide short term relief. T

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

Companies that provide selfless information through particip

he wound should be scanned to make sure no broken spines are left. This will prevent infection

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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