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Most believe that it is problematic for an author to write book reviews about a b

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

ook that they indeed wrote. There are many reasons for this, such as self promoti

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

Examples of combination products may in

on, conflict of interest and hype or buzz-ful insincerity. Sure all that makes se

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

nse for the reasons why we have created this social norm and expect authors to ab

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

ide by it. Yet, in fact it is absurd that everyone else in the world can write bo

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

Combination pro

ok reviews expect the author who knows the most about the work.

This is a Matter

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

of Principle actually, not whether one will be perceived in a negative mindset o

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

r not. That is not a consideration of this philosophical debate, as I score high

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

enough on the EI chart to understand all that and more having marketed products a

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

nd services in my various companies. My point is that it is absurd and unfortunat

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

e that the author is some how considered less of an information source about thei

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

Following aspects would a

r work than Joe Blow writing a book review about it.

Personally, I want to read

dd to the challenges in developing combination products:

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

all that an author has to say about their book. I cannot get enough of that infor

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

mation. What were they thinking, what do they think now, why do they have these o

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

pinions. This information is invaluable to the reader in their understanding, obs

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

ervations and insights learned from a work.

I ask you the reader who is more qua

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

Professional from academic institutions, pharmaceutical industries, health care indust

lified to write a relevant book review? And whose opinion do you think you would

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

value more? I certainly hope this article is of interest and that is has propelle

.

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

d thought. The goal is simple; to help you in your quest to be the best in 2007.

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

Companies that provide selfless information through particip

I thank you for reading my many articles on diverse subjects, which interest you.

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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Just Answers - Writers of Books Should be Allowed to Write Book Reviews of their Literary Work

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