Advice Pool - Writing and Speaking

Franklin Delano Roosevelt had some good advic

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

e for the public speaker when he said, be sin

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

Examples of combination products may in

cere, be brief, be seated. Be simple, natural

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 effective and earn your C’s.

1. Be full

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

Committed to your message and be ready to ta

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

Combination pro

ke action in the face of doubt.

2. Be Compet

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

ent concentrate on your audience and customiz

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

e your remarks to show that you know what is

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

mportant to them.

3. Demonstrate Candor. Tel

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

l your truth. Be vulnerable. Share your misha

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

ps.

4. Challenge yourself and then Challenge

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

Following aspects would a

your audience to think differently, make som

dd to the challenges in developing combination products:

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

change, take some action.

5. Have the Coura

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

ge to talk about uncomfortable things. Don’t

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

only give the audience what they want, but wh

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

at they need to hear.

6. Collaborate, not co

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

Professional from academic institutions, pharmaceutical industries, health care indust

pete, with your audience with your speaker co

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

lleagues.

7. Honor your Covenant with your a

.

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

udience. Understand the awesome opportunity y

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

Companies that provide selfless information through particip

ou have at the platform and take it seriously

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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This article, which first appeared in 1975, in Coil Winding International Magazine, has been updated. Data accumulated over the years in our routine tribological tests substantiated our previous interpretation of the role played by fracture toughness in wear resistance.

The most common method for determining what a home might sell for is the Comparative Market Analysis. This is the method used most often by Realtors. This article explains how to determine the best selling price for a home.

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