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I just finished reading Lawrence Kane’s, “The Way of Kata” for the third time and boy let me tell you that I thoroughly loved this book. It is withou

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

t a doubt one of the, if not the, finest books ever written on the subject of kata and what the techniques in a kata really mean.

This book should b

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

Examples of combination products may in

e required reading for any, and I do mean any, and all individuals who practice a martial art that incorporates kata as a requirement for advancement

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

. Although I knew a quite a bit of information that Lawrence had provided in this book, there was just as much if not more that I didn’t know, or had

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

a slightly different outlook on. Needless to say I was very impressed with the information contained in this book.

This book provides information o

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

Combination pro

the history of kata and the principles and strategy behind it more so than the actual techniques of each particular kata. As you may or may not know

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

, the principles behind the techniques are far more important than the techniques themselves. Too often instructors tend to focus on the least import

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

ant of the two being technique and totally neglect the most important part being the principles behind the technique. Often times this is not truly t

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

he fault of the instructors as they are often unaware of the true meaning behind the techniques in which they teach.

Now normally I do a pretty deta

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

iled analysis of a book when I review it in order to give the reader(s) of my review a good solid understanding of what the particular book I am revi

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

wing is about, and what they can in turn learn from it. However, in this instance, that is not the case. Not that I am unable to do it, quite the opp

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

Following aspects would a

osite, I had initially wrote quite an extensive review. However, after much thought, I decided to forego that particular review in order to take a mo

dd to the challenges in developing combination products:

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

re direct approach.

If you are reading this review, “STOP” right now and go to your local bookstore, Amazon.com, BarnesandNoble.com, or any w

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

here that you can purchase this book and buy it now! Literally, it is that simple, buy this book and sit down and read it cover to cover and then whe

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

n you are finished read it again.

For traditional martial artists who practice kata, this book is easily one of the most influential books that you

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

an buy to improve your skills as a martial artist. Because of the information contained in this book, I would say that it is one of the most importan

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

Professional from academic institutions, pharmaceutical industries, health care indust

t books concerning the traditional martial arts to be published in the last 20+ years.

As the old saying goes, “Practice a technique 1,000 times inc

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

orrectly and you will execute it incorrectly on the 1,001 time. However, if you practice a technique correctly 100 times, chances are you will execut

.

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

e it correctly on the 101 time.”

Without hesitation I can say emphatically that you, and more importantly your instructor(s), will see a remarkable

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

Companies that provide selfless information through particip

improvement in the execution of any of your katas once you have purchased, studied, and implemented the information provided in this outstanding book

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 TQM article is a continuation of the Part 3b article Analyze Phase published on [May 29, 2006 11:28:15 am]. In this issue, the I will share with you some of the difficulties faced with the team in carry out this IMPROVE Phase for this TQM project using the D.A.I.C. methodology as described in the article.

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