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Monday, March 28, 2011
INDIAN PHARMACOPOEIA
INDIAN PHARMACOPOEIA.
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Sunday, March 20, 2011
Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA By Daniel Carpenter .
Publisher: Princeton University Press 2010 | 856 Pages | ISBN: 0691141797 , 0691141800 | PDF | 4 MB
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.
Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.
Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.
Publisher: Princeton University Press 2010 | 856 Pages | ISBN: 0691141797 , 0691141800 | PDF | 4 MB
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.
Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.
Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.
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Chemical Synthesis of Hormones, Pheromones and Other Bioregulators
Kenji Mori, "Chemical Synthesis of Hormones, Pheromones and Other Bioregulators".
Wiley | 2010 | ISBN: 0470697245 | 314 pages | PDF | 2,9 MB
Many small molecules occur naturally as ‘messenger’ chemicals which regulate the behaviour and functions of microbes, plants, insects and animals. Examples include hormones, pheromones, phytoalexins, and antifeedants. These biofunctional molecules are of great interest to researchers as they help to increase our understanding of biological functions and they are useful in the development of new drugs. However, extracting them from nature can be expensive so there is great interest in devising methods of synthesizing them from simple starting materials in a laboratory.
Chemical Synthesis of Hormones, Pheromones and Other Bioregulators is an introduction to techniques and strategies for the synthesis of biofunctional small molecules. Topics include:
biofunctional molecules and organic synthesis
synthesis of phytohormones, phytoalexins and other biofunctional molecules of plant origin
synthesis of insect bioregulators other than pheromones
synthesis of pheromones
synthesis of biofunctional molecules of microbial origin
synthesis of marine bioregulators, medicinals and related compounds
synthetic examination of incorrectly proposed structures of biomolecules
conclusion — science as a human endeavour
Drawing on a career of almost 50 years of researching and teaching this subject, Kenji Mori’s Chemical Synthesis of Hormones, Pheromones and Other Bioregulators is a must-have textbook for students and researchers of organic synthesis and natural products, and a stimulating and inspiring account of a distinguished career in chemicals.
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Wiley | 2010 | ISBN: 0470697245 | 314 pages | PDF | 2,9 MB
Many small molecules occur naturally as ‘messenger’ chemicals which regulate the behaviour and functions of microbes, plants, insects and animals. Examples include hormones, pheromones, phytoalexins, and antifeedants. These biofunctional molecules are of great interest to researchers as they help to increase our understanding of biological functions and they are useful in the development of new drugs. However, extracting them from nature can be expensive so there is great interest in devising methods of synthesizing them from simple starting materials in a laboratory.
Chemical Synthesis of Hormones, Pheromones and Other Bioregulators is an introduction to techniques and strategies for the synthesis of biofunctional small molecules. Topics include:
biofunctional molecules and organic synthesis
synthesis of phytohormones, phytoalexins and other biofunctional molecules of plant origin
synthesis of insect bioregulators other than pheromones
synthesis of pheromones
synthesis of biofunctional molecules of microbial origin
synthesis of marine bioregulators, medicinals and related compounds
synthetic examination of incorrectly proposed structures of biomolecules
conclusion — science as a human endeavour
Drawing on a career of almost 50 years of researching and teaching this subject, Kenji Mori’s Chemical Synthesis of Hormones, Pheromones and Other Bioregulators is a must-have textbook for students and researchers of organic synthesis and natural products, and a stimulating and inspiring account of a distinguished career in chemicals.
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Forecasting for the Pharmaceutical Industry: Models for New Product And In-market Forecasting And How to Use Them
Forecasting for the Pharmaceutical Industry: Models for New Product And In-market Forecasting And How to Use Them By Arthur G. Cook
Publisher: Gower Publishing Company 2006 | 141 Pages | ISBN: 0566086751 | PDF | 11 MB
In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Art Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. "Forecasting for the Pharmaceutical Industry" is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making.
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Publisher: Gower Publishing Company 2006 | 141 Pages | ISBN: 0566086751 | PDF | 11 MB
In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Art Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. "Forecasting for the Pharmaceutical Industry" is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making.
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Cleaning Validation Manual
Syed Imtiaz Haider, Erfan Syed Asif, "Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries"
CRC | 2010 | ISBN: 1439826609 | 608 pages | PDF | 10,1 MB
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.
With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary.
Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.
CRC | 2010 | ISBN: 1439826609 | 608 pages | PDF | 10,1 MB
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.
With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary.
Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.
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