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Solving a big problem is a project: you’re far more likely to solve it successfully if you tre

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

at it like one. That means you’ll need to identify tasks, make and adjust assignments, and kee

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

Examples of combination products may in

p track of what is due when.

Get on the right track immediately by starting a task list as so

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

on as you start working on the problem. Every time you think of something that needs to be don

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, put it on your task list along with the owner, due date and completion criteria (how you’re

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

Combination pro

going to know the task is successfully completed). That way, you won’t have to worry about fo

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

rgetting important details, or waste time constantly reconstructing the list in your mind.

On

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

ce the problem is defined, you can lay out a project schedule and estimate the resources you’l

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

l need. At the very least, you’ll need access to key people who have knowledge of the problem.

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

Some of them may need to be released from other responsibilities to work on your problem-solv

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

ing team. You may also need money for travel, special equipment, exclusive use of a conference

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

Following aspects would a

room, etc. Figuring this out in advance and making sure it is allocated will help you run you

dd to the challenges in developing combination products:

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

r project smoothly.

In addition to the tasks to analyze and solve the problem itself, you’ll

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

also need a communication plan and a contingency plan. The communication plan will identify wh

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

o needs what information about your problem solving effort, when they need it and how you are

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

going to provide it. The contingency plan identifies the things that could stop you from solvi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng the problem and specifies what you are going to do about it. Add the appropriate tasks to i

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

mplement your communication and contingency plans to your task list.

HINT: Orient task

.

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

s to deliverables. Each task should result in something tangible, which will help you make sur

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

Companies that provide selfless information through particip

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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