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ALL armed offenders must be treated as dangerous. They are usually

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

nervous and unpredictable. Some may also be under the influence of

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

Examples of combination products may in

drugs or alcohol.

To increase your chances of surviving an armed r

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

obbery, it is important to:

* Remain calm

* Appear submissive and

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

compliant: obey the armed robber without question can improve perso

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

Combination pro

nal safety

* Raise the alarm only when safe: alarms should only be

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

activated if it is completely safe to do so

* Assist the police b

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

recording all the details, including a description of the offender

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

and statements from witnesses

* Be careful about how the offender

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

is observed, for example avoid direct eye contact

* When dealing

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

ith the media, simply refer them to the police for a statement. Do

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

Following aspects would a

not make statements or answer any questions. The police will supply

dd to the challenges in developing combination products:

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

all the relevant details to the media.

Assisting the police

To a

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

ssist the police following an armed robbery, note the following:

*

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

The time of the offence

* The time the offender left the premises

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

* The weapon/s used or implied

* A description of the offender

*

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

Professional from academic institutions, pharmaceutical industries, health care indust

What the offender took

* Any evidence at the scene

* The directi

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

n the offender left in

* Any transportation the offender used incl

.

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

uding type, make, model, colour, registration and number of occupan

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

Companies that provide selfless information through particip

ts

* Witnesses to the event (they should still be in the premises)

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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