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No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.

Highlights from Sterile Products, Volume�Six include:

• formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
• specifications of a manufacturing facility to manufacture compliant sterile products
• NDA or aNDA filing requirements of sterile products
• an alphabetical presentation of formulations of pharmaceutical products based on their generic names

• Sales Rank: #2072936 in Books
• Brand: Brand: Informa Healthcare
• Published on: 2009-09-21
• Original language: English
• Number of items: 1
• Dimensions: 11.00" h x 1.46" w x 8.50" l, 3.50 pounds
• Binding: Hardcover
• 464 pages

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• Used Book in Good Condition

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[F153.Ebook] PDF Ebook Mikbook : Les cahiers de l'internat

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• Sales Rank: #9592574 in Books
• Original language: French
• Dimensions: 6.50" h x 1.89" w x 9.65" l,
• Binding: Paperback

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[R878.Ebook] Free PDF Marketing Strategies for the New Economy, by Lars Tvede

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Two men meet a big bear in the forest. One of them sits down to put on his running shoes. The other looks at him and says: "It's no use. You cannot outrun a bear anyway". The first one answers: "I don't have to outrun the bear. I just have to outrun you."

Speed against competitors is just one of the key lessons outlined in this book from Lars Tvede and Peter Ohnemus. E-business is here for good and people are waking up to the fact that traditional marketing techniques may not stand up to new requirements set out by the "new economy". The question is, "which of the traditional techniques still work, and which techniques need to be revamped?" The authors outline marketing strategies that use traditional methods where appropriate but, where required, introduce new techniques. These techniques are part of a new, distinctive school of thought in marketing - the 'Digital School of Marketing'. Traditional marketing schools, for example, have observed the importance of moving fast - in the Digital School fast is not just important, it is crucial: it took Microsoft ten years to reach 100 million dollars in revenue, AOL spent nine years, Yahoo! spent five years, Onsale four, Amazon three, and Priceline spent just one and a half years reaching 100 million dollars in revenue. Speed is just one of the key lessons to learn from this book. Whether you are an entrepreneur out there on your own or a marketer in a large company, read on to discover how you can temper your marketing strategies to bring them in line with what is required today.

Synopsis

The high tech industry is expanding and will continue to expand rapidly. Every year it attracts new professionals, some of whom come from other industries that are very different in nature, especially where marketing is concerned. Also, these individuals, whilst technically very able, have limited understanding of marketing. This book will be the definitive guide to anyone involved in the marketing of high tech products and, as such will fill a gap for a book that describes all aspects of marketing management as practised by the most successful executives in the high tech industry. Although there is a plethora of books on the subject of the digital economy, e-commerce and high tech marketing this is the first book to actually provide a comprehensive understanding of the dynamics of the high tech markets. It also contains information on how companies in this sector need to position themselves correctly so that they can capture value; and to provide the information for the creation of a strategy to leverage their resources through co-operation with other companies.

While some aspects of marketing strategy apply across many sectors, there are a number of factors that are distinctive to high-tech businesses. It is therefore of value to any manager in the high-tech industry to understand the specific challenges and opportunities that a marketing strategist will confront when operating within the high-tech industry. Marketing Strategies for the New Economy provides clear explanations of how and where value and profits typically are generated in the high-tech business and how management can develop and execute strategies to position their high-tech companies for lasting success. To give the book a practical edge beyond these concepts, the authors present a "critical path" which is a coherent framework that pulls together these concepts, enabling the reader to implement a winning strategy in this highly competitive field. This work is designed to provide a comprehensive understanding of the dynamics of the high tech markets. It presents examples of marketing plan structures, a high-tech marketing audit, and a chronology of major marketing breakthroughs.

• Sales Rank: #8352690 in Books
• Published on: 2001-03-15
• Original language: English
• Number of items: 1
• Dimensions: 9.25" h x .80" w x 6.28" l, 1.22 pounds
• Binding: Hardcover
• 250 pages

Review
"the advice is sound and it's a must for any Web site having traffic problems." (Internet Works, June 2001)

"..an excellent book which manages to make this topic an interesting read.." (M2 Communications, 5 April 2001)

From the Inside Flap
In creating the 'Digital School of Marketing' Lars Tvede and Peter Ohnemus track the various schools of thought that the field of marketing has witnessed, in a commercial and industrialized society, since it became recognized as a subject in 1902. They demonstrate that much of the teaching from these schools is still relevant but that some aspects of the new economy are truly different and need strategies that have rarely been practiced before. Leading thinkers such as Robert Metcalf, Brian Arthur and Geoffrey Moore could be members of the Digital School and the authors chart their contribution to the types of strategies that will come into being in the new economy. Many of the strategies outlined in this book come from different vantage points than those in traditional marketing. One of the key lessons from the book is based on the traditional concept that the marketing discipline is ultimately the allocation of corporate resource in the pursuit of value - in the new economy you must define the value strategy your company is pursuing before you discuss the marketing parameters. Many more examples of this nature unfold in this book. There is a wealth of knowledge to be gained in the advice put forward by the authors.

From the Back Cover
Two men meet a big bear in the forest. One of them sits down to put on his running shoes. The other looks at him and says, 'It's no use. You can't outrun a bear anyway.' The first one answers, 'I don't have to outrun the bear. I just have to outrun you.' Speed against competitors is just one of the key lessons outlined in this new book from Lars Tvede and Peter Ohnemus. E-business is here for good and people are waking up to the fact that traditional marketing techniques may not stand up to new requirements set out by the 'new economy'. The question is, 'which of the traditional techniques still work, and which techniques need to be revamped?' The authors outline marketing strategies that use traditional methods where appropriate but, where required, introduce new techniques. These techniques are part of a new, distinctive school of thought in marketing - the 'Digital School of Marketing'. Traditional marketing schools, for example, have observed the importance of moving fast - in the Digital School 'fast' is not just important, it's crucial: It took Microsoft 10 years to reach 100 million dollars in revenue, AOL spent nine years, Yahoo! spent five years, Onsale four, Amazon three, and Priceline spent just one and a half years reaching the same amount. Speed is just one of the key lessons to learn from this book. Whether you are an entrepreneur out there on your own or a marketer in a large company, read on to discover how you can temper your marketing strategies to bring them in line with what is required today. Enjoy the race!

Most helpful customer reviews

0 of 0 people found the following review helpful.
Good overview of successful high tech business models
By A Customer
I am a seasoned marketing VP for a high tech company. While I would in no way characterize this as a comprehensive marketing manual for high tech marketers, I did find it very useful from one perspective: it provides a simple overview of what it takes for a company to succeed in the technology space including a very succinct and readable overview of many different value-generating business models. It then relates these business models to appropriate marketing tactics. I gleaned some "nuggets" that will help my company become a more successful enterprise. For this reason alone, the book was well worth the price. It is just over 200 pages and can be read in one sitting.

1 of 2 people found the following review helpful.
Esoteric, not much new
By A Customer
Lots of anecdotal information attempting to tie in the so-called 'New Economy' with historical trends. It doesn't quite convince. A lot of theory, as if meant for an academic audience. I don't see a lot of real world application here. I doubt the authors have experience running a successful real-world business.

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[C444.Ebook] Free PDF Organizational Health: An Integrated Approach to Building Optimum Performance, by Naomi Stanford

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While the management world has been focused on solving problems, it should be working to maintain effectiveness and organizational health, says Naomi Stanford. She believes organizational health -- an organization's ability to function effectively and change appropriately -- can be sustained if managers take preventative action to maintain effectiveness rather than waiting for problems to arise and dealing with them as things to go wrong.

Organizational Health takes an informed look at the critical and interdependent elements of an organization that must be maintained in a healthy state for managers to meet their business goals. Topics covered include: the understanding and assessment of organizational health; control methods such as corporate governance, ethics and compliance; maintenance and development including organizational design and change management; sustainability including carbon footprint and business ecosystems; the indicators of health and dysfunction.

Each chapter includes input, reflective questions, case studies and an exercise for readers to work with in their organization so they can learn by doing. One of the first to apply these ideas at an organizational level, this book explains that maintaining an organization's health is an ongoing process with no secret formula -- just paying attention and planning.

• Sales Rank: #150805 in Books
• Brand: Brand: Kogan Page
• Published on: 2013-01-28
• Original language: English
• Number of items: 1
• Dimensions: 9.00" h x .58" w x 6.00" l, 1.92 pounds
• Binding: Paperback
• 253 pages

Features

• Used Book in Good Condition

Review
OD practitioners, HR managers

"[A] recommended pick for any manager who wants case studies paired with exercises to help students understand the culture and business relationships within an organization. ...[A] solid primer geared for college-level students of business and organizational analysis." (California Bookwatch Midwest Book Review)

About the Author

Dr. Naomi Stanford is an expert organization design and development consultant based in Washington, DC. She supervises doctoral students in the School of Business and Technology at Capella University. She has also consulted with, and worked in, many sectors and industries including Fortune 500 companies, government agencies, and non profits. She is an experienced author in the field and her books include The Economist Guide to Organization Design, Organization Design: The Collaborative Approach, and Corporate Culture: Getting it Right

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[T113.Ebook] Free PDF International Business (2nd Edition), by Stuart Wall, Bronwen Rees

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International Business provides an accessible and theoretically rigorous introduction to the subject. Starting with an in-depth analysis of the environmental factors, the book then examines the functional and operational issues which organisations face in doing business internationally. This coherent structure is supported by a strong pedagogical framework within the text, and further substantial resources available on a companion website. The second edition of the text offers a thorough update of all material. New and revised cases and examples are extended to incorporate FT articles and extracts, allowing students to see the practical applications of the key concepts. A great supplementary package supports this text which can be obtained through its companion website www.booksites.net/wallrees

• Sales Rank: #6150408 in Books
• Published on: 2005-01-02
• Original language: English
• Number of items: 1
• Dimensions: 9.68" h x .86" w x 7.46" l, 1.80 pounds
• Binding: Paperback
• 432 pages

From the Back Cover

�

International Business provides an accessible and theoretically rigorous introduction to the subject. Starting with an�analysis of�external environmental factors, the book�moves to�examine the functional and operational issues�faced by international businesses. Throughout the text, more subtle organisational and cultural isues, increasingly crucial to success, are given strong prominence.

The throroughly updated second edition�provides new�cases�and FT articles, encouraging the reader to explore�the practical applications of the key concepts. There is also an increased emphasis on international strategic directions to highlight the importance of long-term business planning. A coherent structure is supported by a strong pedagogical framework, with further substantial resources available on the book's website at www.booksites.net/wallrees.

Ideally suited for undergraduate and postgraduate degrees and modules in International Business, the book will also appeal to�'non-specialist' students from disciplines outside business and management.

Key Features

• Emphasis on culture, ethics and the environment
• New Chapter 8: International strategic issues
• New and revised case material and FT articles
• Broad coverage of key environmental and operational factors
• Strong pedagogical structure enabling and active and open-learning approach
• Companion�website�provides resources for both students and lecturers

Stuart Wall is Subject Leader in�Business and Economics at Ashcroft International Business School, Anglia Polytechnic University and has acted as a consultant on international business issues for the OECD.�Bronwen Rees is Senior Research Fellow, also at Ashcroft International Business School, and has been a Visiting Fellow at both Cranfield School of Management and Judge�Institute, Cambridge University.

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• Sales Rank: #4315581 in Books
• Published on: 1707
• Binding: Hardcover

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[R198.Ebook] Download Ebook Hybrid Modernities: Architecture and Representation at the 1931 Colonial Exposition, Paris (MIT Press), by Patricia A. Morton

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The 1931 International Colonial Exposition in Paris was a demonstration of French colonial policy, colonial architecture and urban planning, and the scientific and philosophical theories that justified colonialism. The Exposition displayed the people, material culture, raw materials, manufactured goods, and arts of the global colonial empires. Yet the event gave a contradictory message of the colonies as the "Orient" -- the site of rampant sensuality, decadence, and irrationality -- and as the laboratory of Western rationality. In Hybrid Modernities, Patricia Morton shows how the Exposition failed to keep colonialism's two spheres separate, instead creating hybrids of French and native culture.At the Exposition, French pavilions demonstrated Europe's sophistication in art deco style, while the colonial pavilions were "authentic" native environments for displaying indigenous peoples and artifacts from the colonies. The authenticity of these pavilions' exteriors was contradicted by vaguely exotic interiors filled with didactic exhibition stands and dioramas. Intended to maintain a segregation of colonized and colonizer, the colonial pavilions instead were mixtures of European and native architecture.Anticolonial resistance erupted around the Exposition in the form of protests, anticolonial tracts, and a countercolonial exposition produced by the Surrealists. Thus the Exposition occupied a "middle region" of experience where the norms, rules, and systems of French colonialism both emerged and broke down, unsustainable because of their internal contradictions. As Morton shows, the effort to segregate France and her colonies failed, both at the Colonial Exposition and in greater France, because it was constantly undermined by the hybrids that modern colonialism itself produced.

• Sales Rank: #2394921 in Books
• Published on: 2003-02-28
• Original language: English
• Number of items: 1
• Dimensions: 9.00" h x 1.00" w x 7.00" l, 1.70 pounds
• Binding: Paperback
• 390 pages

Review

In Hybrid Modernities Professor Patricia Morton combines architectural history and postcolonial theory in a complex, richly nuanced account of that ever-fascinating spectacle, the 1931 Colonial Exposition in Paris. The book adds a new dimension to the story of Greater France, and is must reading for all those interested in imperial encounters and their legacies for the modern world.

(Tyler Stovall, Professor of History, University of California)

About the Author

Patricia A. Morton, an architectural historian, teaches in the Art History Department at the University of California, Riverside.

Sheldon Zink, Ph.D., is a Senior Fellow and Director of the Program for Transplant Policy and Ethics at the University of Pennsylvania Center for Bioethics. She is preparing a book about her experiencesas the ethnographer and patient advocate for the recent clinicaltrial for the total artificial heart.

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4 of 4 people found the following review helpful.
High Point of the French Colonial Project
By Marco Antonio Abarca
The French reconciled the ideals of "Liberte, Egalite and Fraternite" with the harsh reality of colonialism by cloaking their endeavor in the terms of the "Mission Civilisatrice". They believed that through conquest, they were assisting less developed people by exposing them to French Civilization, the highest manefestation of Western Civilization. For this mission to be sucessful, the Governement understood the importance of selling this "noble" idea to the French people. In 1931, the Governement held the International Colonial Exposition in Paris. The Exposition was to be a demonstration of superior French ability in the areas of administration, architecture, urban planning and scientific knowledge. The Exposition was a complete success. During its six month run, over 30 million tickets were sold to the Exposition. This Exposition was the high point of French Colonialism. At the time, nobody knew that within thirty years, the French Colonial Empire would come crashing down.

"Hybrid Modernities" is a well written and lavishly illustrated study of the 1931 Exposition. Patricia Morton masterfully deconstructs the political purpose of the Exposition. With an art historian's careful eye, she shows how the architecture of the individual country pavillions was harnassed to serve the political and economic agenda of the French Government.

There are several target audiences for this book. "Hybrid Modernities" is a must for anyone interested in understanding France's troubled relationship with its colonies. The book will also be of interest to those studying the social history of Paris in the 1930's. Finally, this book will be enjoyed by students of French Art Deco Architecture. "Hybrid Modernities" is a thought provoking and throughly enjoyable read.

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Expressways, by Steven J. Molinsky and Bill Bliss, is a complete four-level course that features all-skills language practice. The series incorporates cooperative learning, critical thinking, problem solving, role-playing, cross-cultural discussions, self-assessment, and community activities to promote an interactive, student-centered learning experience. New Activity and Test Prep Workbooks provide a variety of exercises and activities for reinforcing grammar, and grammar and test-taking practice to prepare students for standardized tests.

• Sales Rank: #329053 in Books
• Color: Other
• Published on: 1995-07-28
• Original language: English
• Number of items: 1
• Dimensions: 10.70" h x .50" w x 8.20" l, 1.11 pounds
• Binding: Paperback
• 224 pages

From the Back Cover

Expressways is a complete four-level course that features all-skills language practice. The series incorporates cooperative learning, critical thinking, problem solving, role-playing, cross-cultural discussions, self-assessment, and community activities to promote an interactive, student-centered learning experience.

• Student Texts contain high-interest readings that integrate life skill topic, functions, and grammar with role-playing, group discussion, and cooperative learning.
• The Teacher's Guide provides step-by-step instructions for each lesson.
• New

Activity and Test Prep Workbooks provide a variety of exercises and activities for reinforcing grammar, and grammar and test-taking practice to prepare students for standardized tests.

The Testing Program includes a placement test and end-of-chapter achievement tests.

Audio Programs for both the Student Books and the Activity Workbooks provide realistic recordings of dialogue and activities.

About the Author
Sarah Lynn's three young sons taught her how to race toy cars. Together they?ve used their imaginations to create roads everywhere (couch, kitchen floor, dirt, sand, rug, and the bathtub, just for starters.) The idea for 1-2-3 Va-Va-Vroom! came to Sarah when she was teaching her oldest son to write numbers. They began imagining the pencil as a car drawing its own track. Those vroom-vroom sounds made writing numbers so much more fun. Sarah is also the author of Tip-Tap Pop, illustrated by Valeria Docampo. She lives with her family in Camarillo, California.

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4 of 4 people found the following review helpful.
An Effective Langauge Series
By Paul S. Remington
The Expressways series of textbooks is designed to accelerate an English student's language mastery through exercises that teach visually through reading, tactilely through writing, and audibly through speaking. The student's abilities mature through practicing these skills for proper mastery of the English language.

My wife is a Chinese native who recently began English as a Second Language (ESL) courses at our local high school. The instructor uses these textbooks as the primary tool for learning. We have found them to be an effective and fun way to learn together as a couple and it has helped her language skills and personal confidence.

The exercises in the textbook are designed for a classroom setting or, if a classroom is not available, for practice with a partner. My wife benefits through classroom interaction twice a week and by working with me.

It is very important the student is able to work with someone to practice the lessons in the book. I would strongly suggest purchasing the companion workbook that accompanies this textbook for added exercises. There is also an audio component to this series that can be helpful, but if the student will be in a classroom or can practice daily with an English-speaking person, the audio is not necessary.

The conversational lessons in the textbook use iteration to teach. The student practices scripted conversations with a partner and phrases are changed to vary the meaning. The conversation remains similar each time, which reinforces the language structure, and the student learns through familiarity and practice. This is a crucial component to the learning process.

In addition to the interactive components are lessons that teach the correct grammatical structure of English sentences. Lessons force the student to think about what they're saying and practice the rules and logic in their mind before selecting the best answer. These grammatical lessons are reinforced through the practice conversations.

I would recommend the Expressways series for anyone who wants to increase their English mastery, but it is vitally important the student has a partner to assist with the lessons. This is best accomplished in a classroom setting at least once a week and/or with a friend or loved one close to the student. This is not a self-study textbook. While some of the lessons are accomplished alone, the real learning comes through verbal interaction and practice.

If you do not have access to a classroom or study partner, purchase the audio component along with the textbook and seek-out English speaking people to talk to.

With time, persistence, and practice, your English skills will increase, and the Expressways series of language textbooks will help you accomplish your goals.

0 of 0 people found the following review helpful.
good
By Andy
This workbook gives beginning English learners a great review in the four basic skills of listening, speaking, reading and writing. In addition, there are grammar raps or jazz-like songs for pronunciation, intonation and rhythm practices. Check-up tests after every three lessons make a teacher's task much easier.
I have used the Side by Side series for years and found them very well-organized, interestingly designed and user-friendly both for students and teachers. To help students improve writing even more, I usually ask them to write out complete answers in their notebooks instead of just filling out the blanks in the workbooks.

0 of 0 people found the following review helpful.
Expressways Book 1
By The Cat
This book is a very easy to use from the point of view of an instructor or student. The student can learn and do the exercises provided in the book with little explanation, right away. It is a very simple book to use because even without a lesson plan any teacher is able to explain and teach this book in class. I think this book provides a win/win situation for the teacher and for the students. Everyone wins by using this book.

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'A superbly written play, a funny play, an agonising play. It is, moreover, a play of truth and insight. A play to savour.'
Punch on Otherwise Engaged

'Life in the theatre hasn't brought me anything more rewarding than directing Simon Gray's plays.'
Harold Pinter

Plaintiffs and Defendants
Exceptionally good... the play gave such a rending picture of married mess that it was hard to know where to look.' Clive James, Observer

'Simon Gray is the one [TV playwright] whose work I most relish seeing for his acerbic wit, wonderful ironies and above all for his care with our mother tongue.' Dennis Potter

• Sales Rank: #2113233 in eBooks
• Published on: 2013-05-02
• Released on: 2013-05-02
• Format: Kindle eBook

About the Author
Simon Gray was born in 1936. He began his writing career with Colmain (1963), the first of five novels, all published by Faber. He is the author of many plays for TV and radio, also films, including the 1987 adaptation of J L Carr's A Month in the Country, and TV films including the Emmy Award-winning Unnatural Pursuits. He wrote more than thirty stage plays amongst them Butley and Otherwise Engaged (which both received Evening Standard Awards for Best Play), The Common Pursuit, Hidden Laughter and The Late Middle Classes (winner of the Barclay's Best Play Award). In 1991 he was made BAFTA Writer of the Year. His acclaimed works of non-fiction include his Early Diaries, The Smoking Diaries and Coda. He was appointed CBE in the 2005 New Year's Honours for his services to Drama and Literature. Simon Gray died in August 2008.

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Simon Gray: Plays 2: Otherwise Engaged; Dog Days; Molly; Plaintiff and Defendants; Two Sundays; Pig in a Poke; Man in a Side Car, by Simon PDF

Simon Gray: Plays 2: Otherwise Engaged; Dog Days; Molly; Plaintiff and Defendants; Two Sundays; Pig in a Poke; Man in a Side Car, by Simon PDF

Simon Gray: Plays 2: Otherwise Engaged; Dog Days; Molly; Plaintiff and Defendants; Two Sundays; Pig in a Poke; Man in a Side Car, by Simon PDF

Simon Gray: Plays 2: Otherwise Engaged; Dog Days; Molly; Plaintiff and Defendants; Two Sundays; Pig in a Poke; Man in a Side Car, by Simon PDF