Digg It - Business

A graduate level class in managerial decision making teaches a process for making decisions and analyzin

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

g risks. The process uses typical inputs and outputs in an organiation such as materials, information,

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

Examples of combination products may in

employees, new products, and resource allocation.

The process does two things. First, it provides a lo

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

ical way to analyze information and integrates diverse tasks and work processes. Secondly, the process

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

analyzes management behavior and links a variety of activities and concludes with a coherent and orderly

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

Combination pro

view of management.

The variety of work activities are considered as processes starting with organizati

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

onal processes. Organizational processes are divided into three areas: work processes, behavioral proc

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

sses, and change processes. These processes break down further into areas such as communication process

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

es, organizational learning processes, change processes, managerial processes, direction-setting process

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

s, and many other work activities that are processes.

The decision-making and risk analysis processes w

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

ere analyzed using software that considered all the possibilities, assigned probabilities, integrated va

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

Following aspects would a

rious factors, and led to a calculated decision. The software creates a decision-making tree, a risk an

dd to the challenges in developing combination products:

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

lysis model, an influence factor model, and simulated variations. The software used in the class was ma

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

de by Palisades, but there are other creators of decision-making soft such as Decision Pro.

If you want

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

to systematically analyze the decisions you have to make and your exposue to risk, you may want to consi

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

der decision-making software. The software can be found on the internet, and they usually allow you to

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

Professional from academic institutions, pharmaceutical industries, health care indust

ownload trial versions. It is interesting, but complicated to use.

Jo Ann Joy, Esq., MBA, CEO

Cop

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

.

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

) 663-7007, by fax at (602) 324-7582, by email at joannjoy@Indigo Business Solutions.net, and by

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

Companies that provide selfless information through particip

mail at 2313 East Ocotillo Rd., Phoenix, AZ 85016

The future of your business starts here!

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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Digg It - Decision-Making and Risk Analysis

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