Quality Progress - June 2008
Far-Sighted
In the first year nonprofit organizations could apply for the honor, Coral Springs became the first local government to take home a Baldrige award by proving it didn't emphasize the present at the expense of the future....
Customer Servicemen
Customer Feedback is a key component of improvement. The challenge has always been finding the most effective way of procuring it....
Incredible Journey
In response to personnel’s safety concerns and rising workers’ compensation costs, a team at Boeing’s C-17 site developed a solution to thwart injury and save money....
Two Are Better Than One
Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....
The True Test of Loyalty
The customer loyalty field has experienced much technological innovation, such as automated reporting portals and integration of attitudinal and behavioral data in customer relationship management applications, over the past decade....
Who's Keeping Score?
There’s one tool you won’t find for sale at Sears. One of the retail giant’s divisions has started using a quality management tool extensively to maintain and improve its own quality management system....
Download
http://rapidshare.com/files/181002722/tqp0608.zip
Quality Progress - February 2008
Sharpen Your Auditing Skills
Effective audits require effective audit planning. One of the best tools to help guide both the planning and execution of an audit is the audit checklist....
Efficiency Gets a New Identity
This article demonstrates the impact RFID will have on existing supply chain processes and the improvements RFID implementation will bring by comparing the benefits of RFID with those of barcode for various supply chain entities. The increases in data cap..
Educating Engineers
Statistics is an indispensable tool for solving engineering problems. But many engineers are not exposed to problems that require the use of statistical methods until they start their professional careers....
Good Vibrations
Modern quality management principles define quality as customer satisfaction with product and service. SCGC has a web page where guitar owners can have questions about their guitars answered by Hoover or Roberts. With employee empowerment accompanying goo...
Launch to Quality
After using different quality methods with limited success, the Naval Surface Warfare Center, Indian Head Division, implemented lean Six Sigma in 2004. Through all of this, leadership demonstrated a steadfast commitment to fully implementing lean Six Sigm...
Download
http://rapidshare.com/files/180961213/tqp0208.zip
Quality Progress - March 2008
A Framework for Business Ethics
Profit maximization is, of course, the main and foremost objective for any commercial organization. Most modern organizations realize that to survive in today’s competitive arena, customers have to be satisfied....
A Gold Medal Solution
Additionally, the production team's performance wasn't meeting its organizational goals—including quality, timeliness, efficiency and cycle time—for continuous improvement. Internal stakeholders included those from in-plant manufacturing, safety, and prod...
The Remedy for a Data Dilemma
In 1994, Bellin Health volunteered for a pilot assessment managed jointly by the Baldrige National Quality Program and the Joint Commission. This assessment helped Bellin focus on developing an integrated measurement system....
Strong Foundation, Solid Future
In the wake of the scandals five years ago that shook consumer confidence in business leaders and the economy, I co-wrote an article about the resurgence of social responsibility on the corporate landscape and increased public awareness on the topic....
Download
http://rapidshare.com/files/180952830/tqp0308.zip
Controlled Environments - November 2008
BIOLOGICAL SAFETY CABINETS: CONTROLLING CONTAMINATION David Phillips 16
ACHIEVING TRUE EH&S IN CONTROLLED ENVIRONMENTS
Matt Kopecky
CLEANROOM FACILITY CONSTRUCTION OPTIONS
REGULATORY FORUM:
PREDICTING THE FUTURE
Bikash Chatterjee
CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM
THINKING OUTSIDE THE BOX (OR AT LEAST OUTSIDE THE SEM)
Barbara Kanegsberg and Ed Kanegsberg
C4: CRITICAL CLEANING FOR CONTAMINATION CONTROL
MAYBE HEISENBERG WAS WRONG, AND EINSTEIN RIGHT?
John Durkee, Ph.D., P.E 9 EDITOR’S LETTER 25 PRODUCT FOCUS:
INSTRUMENTATION
BUSINESS MARKETPLACE
PENCIL IT IN
ADVERTISER INDEX
Download
http://rapidshare.com/files/162638164/tctrl_envir_nov08.zip
CleanRooms - Magazines (Jan 08 to Oct 08)
Magazine of contamination control and clean manufacturing for clean room professionals in the semiconductor, biotechnology, life sciences, and cosmetic manufacturing.
The entire package of the year 2008 from January to September.
Download
http://rapidshare.com/files/162638164/tctrl_envir_nov08.zip
Regulatory Focus - September 2008
Where is our profession headed?
A Seat at the Table:Regulatory in Corporate Health care
Managing Global Business Risk:The New Role of Regulatory Leaders
Mergers, Acquisitions and Operational Risk
The Regulatory Professional:A Jack of All Trades
Regulating Nanotechnology in the US & EU
Download
http://rapidshare.com/files/147610224/tregu_focus_sep08.zip
Powder and Bulk Engineering International Sep/Oct-2008
Powder and Bulk Engineering International [ISSN 1098-6480] is pub -lished six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120. After several years of not being published, Powder and Bulk Engineering International is back!
ARTICLES:
Basic criteria for selecting a bagging system Walter Kersting
Case History: FFS bagging adds flexibility at feed plant
Case History: Conveyor dryers increase capacity, ensure quality at
Thai Luxe
A preview of new products on display at POWTECH 2008
POWTECH 2008 exhibitor list
DEPARTMENTS:
Industry news
Engineering literature: Bin Dischargers
Equipment feature: Bagging and Packaging
Equipment feature: Drying
Engineering literature: Rotary Airlocks
Product update
Supplier news
People news
Events
Advertiser index
Download
http://rapidshare.com/files/145930014/Powbulk_eng_int0908.zip
Pharmaceutical Engineering - July/August 2008
Table of Contents: Articles
Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process
by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.
Download
http://rapidshare.com/files/143522981/tpharma_eng_ja8.zip
Pharmaceutical Engineering - May/June 2008
Table of Contents
Articles
A Risk-Based Approach to Cleaning Validation using Visible Residue Limits
by Richard J. Forsyth and Jeffrey L. Hartman
This article describes the development of a Visible Residue Limits (VRL) program in a pharmaceutical manufacturing facility, including sample and viewing parameters. Opportunities for VRL implementation were identified in both pilot plant and manufacturing settings.
GAMP 5 Quality Risk Management Approach
by Kevin C. Martin and Dr. Arthur (Randy) Perez
This article describes how the GAMP 5 quality risk management strategy offers a pragmatic approach to computer systems compliance.
Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness
by Christian Woelbeling and the Regional PAT COP from ISPE DACH Affiliate
This article summarizes the first four chapters of the PAT awareness document created by the PAT COP and explains how QbD/PAT management awareness can be created.
Industry Interview Series: Ruediger Dorn, Managing Director, Worldwide Pharmaceutical Industry, Microsoft
In this interview, Ruediger Dorn discusses Microsoft’s focus on the life sciences and the evolving relationship between plant operations and IT. Speaking from experience in auto manufacturing, he gives his thoughts on current challenges in the pharmaceutical industry.
Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES)
by Joseph F. deSpautz and Gregory Ruklic
This article summarizes the domain methodology described in the GAMP® Good Practice Guide on Manufacturing Execution Systems currently under development.
Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System
by Gamal Amer
This article identifies ways to mitigate the risk associated with the manufacture of drug products.
On-line Exclusive Articles
Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord and Michael Porter
This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans, ISPE Technical Documents Writer/Editor
Introduction to ICH: Essential Background to PQLI
by Dr. Kate E. McCormick, ISPE European Education Advisor
Global Regulatory News
Download
http://rapidshare.com/files/142215077/tpharma_eng_mj8.zip
Controlled Environments May 2008
Controlled Environments - a monthly magazine focused on clean room requirements for aspectic/sterile pharmaceutical & microelectronics manufacturing detailing latest developments in the technology, vista on the scientific background and much more.
Download Link:
http://rapidshare.com/files/125318636/Cont_envir58.zip
Wednesday, February 4, 2009
clinical research
The Design of Studies for Medical Research
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.
Download
http://rapidshare.com/files/191221137/tdsgn_stud_med_res.zip
Opioid Research: Methods and Protocols
Univ. of Texas MD Anderson Cancer Center, Houston. Text provides a comprehensive collection of methods and protocols used in current opioid research. Covers molecular and genetic techniques and behavioral analysis of animal models. Provides state-of-the-art techniques plus clinical applications. For researchers and practitioners.
Download
http://rapidshare.com/files/175661701/topresear_metho_proto.zip
Encyclopedia of Analytical Chemistry: Applications, Theory, and Instrumentation
The highly acclaimed Encyclopedia of Analytical Chemistry provides a much needed professional level reference work for the 21st Century. Encyclopedia of Analytical Chemistry is the most comprehensive analytical chemistry reference available, covering all aspects from theory and instrumentation through applications and techniques.
The chemistry and techniques are described as performed in the laboratory (environmental, clinical, QC, research, university), in the field or by remote sensing. The level of detail is similar to that of a lab protocol and together with the cited references, will support the analysis of complex inorganic, organic and biological structures by academic and industrial researchers. Encyclopedia of Analytical Chemistry also enables preparation of procedures, protocols and "cookbooks" by managers and staff of laboratories.
Encyclopedia of Analytical Chemistry comprises over 600 articles, arranged alphabetically by topic, in approximately 14000 pages, in 15 volumes.
Features:
* Outstanding authorship and the highest calibre editors
* Excellence of peer-review
* Article Summaries
* Over 6500 illustrations, many in colour
* Extensive cross-referencing to facilitate navigation between articles
* Extensive bibliographies with up-to-date references
Encyclopedia of Analytical Chemistry is the essential cross-disciplinary reference work for all analytical chemists in academia and industry. All fields of chemical research are covered: analytical, organic, physical, polymer, inorganic biomedical, environmental, pharmaceutical, industrial, petroleum, forensics and food science.
Download
http://rapidshare.com/files/167164034/tencyclo_ana_chem.zip
Pharmaceutical Experimental Design
This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.
Download
http://rapidshare.com/files/161402071/tpharma_exp_dgn.zip
Designing Clinical Research: An Epidemiologic Approach
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Download
http://rapidshare.com/files/148468744/tdesigning_clin_rese.zip
Clinical Studies Management - A Practical Guide to Success
A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.
Download
http://rapidshare.com/files/139169695/Csm_guide.zip
Laboratory Animal Law: Legal Control of the Use of Animals in Research
“It is hard to see how anyone with responsibilities under the Animals (Scientific Procedures) Act could manage without a book such as this.” Michael Balls, review published in Atla
“The strength of the book lies in the way Kevin Dolan brings his experience to bear blending information from various sources.” Patrick Sinnett-Smith, review published in RDS News
Written by the leading expert in this field, this is the only book providing practical guidance on the legal obligations of caring for laboratory animals. Up-to-date information on all relevant UK legislation and guidelines is given, with the main emphasis being on the interpretation of the Animals (Scientific Procedures) Act 1986.
New to this edition:
*Emphasis throughout is now on the practical application of legal controls of the use of animals in research.
*Updated where relevant to keep in line with new welfare legislation.
*Coverage of current format of application for personal and project licences.
*Expanded coverage of Certificates of Designation.
*Impact of the Freedom of Information Act is discussed.
A vital resource for all those involved with the use of animals in research, and especially those studying for qualifications or licences in this field.
Download Link:
http://rapidshare.com/files/135449791/Lab_animal_law.zip
Conducting GCP- Compliant Clinical Research: A Practical Guide
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:
* Standard operating procedures for investigators
* Standard operating procedures for sponsors and CROs
* GCP - an indexed reference
Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.
Download Link:
http://rapidshare.com/files/133736102/tgcp_CR.zip
Good Clinical Practice: Standard Operating Procedures for Clinical Researchers
Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:
* A brief description of the history and development of clinical research and good clinical practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.
Download Link:
http://rapidshare.com/files/132314267/GCP_SOP_CR.zip
Practical Guide to Clinical Data Management
Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.
Download Link:
http://rapidshare.com/files/126960497/Pra_gud_clin_dm2Ed.zip
Clinical Data Management
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.
It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Download Link:
http://rapidshare.com/files/119011644/Clin_dta_mgmet.zip
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.
Download
http://rapidshare.com/files/191221137/tdsgn_stud_med_res.zip
Opioid Research: Methods and Protocols
Univ. of Texas MD Anderson Cancer Center, Houston. Text provides a comprehensive collection of methods and protocols used in current opioid research. Covers molecular and genetic techniques and behavioral analysis of animal models. Provides state-of-the-art techniques plus clinical applications. For researchers and practitioners.
Download
http://rapidshare.com/files/175661701/topresear_metho_proto.zip
Encyclopedia of Analytical Chemistry: Applications, Theory, and Instrumentation
The highly acclaimed Encyclopedia of Analytical Chemistry provides a much needed professional level reference work for the 21st Century. Encyclopedia of Analytical Chemistry is the most comprehensive analytical chemistry reference available, covering all aspects from theory and instrumentation through applications and techniques.
The chemistry and techniques are described as performed in the laboratory (environmental, clinical, QC, research, university), in the field or by remote sensing. The level of detail is similar to that of a lab protocol and together with the cited references, will support the analysis of complex inorganic, organic and biological structures by academic and industrial researchers. Encyclopedia of Analytical Chemistry also enables preparation of procedures, protocols and "cookbooks" by managers and staff of laboratories.
Encyclopedia of Analytical Chemistry comprises over 600 articles, arranged alphabetically by topic, in approximately 14000 pages, in 15 volumes.
Features:
* Outstanding authorship and the highest calibre editors
* Excellence of peer-review
* Article Summaries
* Over 6500 illustrations, many in colour
* Extensive cross-referencing to facilitate navigation between articles
* Extensive bibliographies with up-to-date references
Encyclopedia of Analytical Chemistry is the essential cross-disciplinary reference work for all analytical chemists in academia and industry. All fields of chemical research are covered: analytical, organic, physical, polymer, inorganic biomedical, environmental, pharmaceutical, industrial, petroleum, forensics and food science.
Download
http://rapidshare.com/files/167164034/tencyclo_ana_chem.zip
Pharmaceutical Experimental Design
This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.
Download
http://rapidshare.com/files/161402071/tpharma_exp_dgn.zip
Designing Clinical Research: An Epidemiologic Approach
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Download
http://rapidshare.com/files/148468744/tdesigning_clin_rese.zip
Clinical Studies Management - A Practical Guide to Success
A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.
Download
http://rapidshare.com/files/139169695/Csm_guide.zip
Laboratory Animal Law: Legal Control of the Use of Animals in Research
“It is hard to see how anyone with responsibilities under the Animals (Scientific Procedures) Act could manage without a book such as this.” Michael Balls, review published in Atla
“The strength of the book lies in the way Kevin Dolan brings his experience to bear blending information from various sources.” Patrick Sinnett-Smith, review published in RDS News
Written by the leading expert in this field, this is the only book providing practical guidance on the legal obligations of caring for laboratory animals. Up-to-date information on all relevant UK legislation and guidelines is given, with the main emphasis being on the interpretation of the Animals (Scientific Procedures) Act 1986.
New to this edition:
*Emphasis throughout is now on the practical application of legal controls of the use of animals in research.
*Updated where relevant to keep in line with new welfare legislation.
*Coverage of current format of application for personal and project licences.
*Expanded coverage of Certificates of Designation.
*Impact of the Freedom of Information Act is discussed.
A vital resource for all those involved with the use of animals in research, and especially those studying for qualifications or licences in this field.
Download Link:
http://rapidshare.com/files/135449791/Lab_animal_law.zip
Conducting GCP- Compliant Clinical Research: A Practical Guide
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:
* Standard operating procedures for investigators
* Standard operating procedures for sponsors and CROs
* GCP - an indexed reference
Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.
Download Link:
http://rapidshare.com/files/133736102/tgcp_CR.zip
Good Clinical Practice: Standard Operating Procedures for Clinical Researchers
Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:
* A brief description of the history and development of clinical research and good clinical practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.
Download Link:
http://rapidshare.com/files/132314267/GCP_SOP_CR.zip
Practical Guide to Clinical Data Management
Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.
Download Link:
http://rapidshare.com/files/126960497/Pra_gud_clin_dm2Ed.zip
Clinical Data Management
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.
It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Download Link:
http://rapidshare.com/files/119011644/Clin_dta_mgmet.zip
pharmaceutical biotechnology
The textbook on pharmaceutical Biotechnology provides comprehensively the fundamental concepts and principles in Biotechnology to expatiate and substantiate its numerous modern applications with regard to the spectacular development in the Pharmaceutical Industry. In a broader perspective, the students studying Biotechnology at undergraduate and postgraduate levels shall be grossly benefited by its well-planned systematically developed, structured, illustrated, expanded, elaborated, and profusely exemplified subject matter.It essentially comprise five major chapters, namely: Immunology and Immunological Preparations; Genetic Recombination; Antibiotics; Microbial Transformations; and Enzyme Immobilization. Besides, there are five auxiliary chapters, namely, Advent of Biotechnology; Biosensor Technology; Bioinformatics and Data Mining; Regulatory Issues in Biotechnology; and Safety in Biotechnology, which have been specifically included so as to stimulate the students, interest and broaden their horizon of knowledge and wisdom.The authors earnestly believe that the wide coverage of various topics mentioned above would certainly render Pharmaceutical Biotechnology to serve as an exclusive source of information`s, ideas, inspirations towards research, and finding newer possible practical solutions to problems encountered in the ever green pasture using knowledge of Biotechnology in the Pharmaceutical Industry. Contents Immunology and Immunological Preparations
Genetic Recombination
Microbial Transformations
Enzyme Immobilization
Advent of Biotechnology
Biosensor Technology
Bioinformatics and Data Mining
Regulatory Issues in Biotechnology
Safety in Biotechnology
link:-
http://rapidshare.com/files/193285299/tpharma_tbiotecht.zip
Genetic Recombination
Microbial Transformations
Enzyme Immobilization
Advent of Biotechnology
Biosensor Technology
Bioinformatics and Data Mining
Regulatory Issues in Biotechnology
Safety in Biotechnology
link:-
http://rapidshare.com/files/193285299/tpharma_tbiotecht.zip
Subscribe to:
Posts (Atom)
Posts
