Book Description

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories. ... Read more

Reviews (3)

Good guide to EBM
Greenhalgh's book is a great read for someone familiar with medical and research terminology. As a med student, I loved it and found it very practical. It contains a great deal of material on how to evaluate the type, methodology, and statistical methods of research papers. There is no glossary, and in places the layout is hard to look at.

Short on Substance
"How to Read a Paper" reads more like a short essay than a book. While it is well written and often full of spirited discussion, this text is somewhat short on substance and generally too simplistic. The author rarely delves beyond the surface when explaining and exporoing this field, leaving me, at least, unsatisfied. Whereas a simplistic approach to any field may be useful, the amplification of themes once introduced is where real learning occurs. This book falls short, where several other excellent texts in this field carry on. I do like the author's style, and would encourage her to scribe a more thorough text... but if I were you I'd wait for that effort before buying this one.

A good place to start
Greenhalgh's book is a good place to start if you want to learn how to consume research articles. The target audience for this book is those primarily interested in health research, but it useful for all those who must make their way through journal articles. Greenhalgh goes through the basics and touches on important issues. However, it is important to point out that this book is only a first step in understanding how to read journal articles. ... Read more

Book Description

This introductory reference provides a practical, concise summary of everything a physician needs to know about genomics and emerging technologies. Through extensive illustrative examples, this book offers a clear and concise starting point to understanding how medicine has been, and will be, transformed by genomics and bioinformatics. Beginning with a clear overview on the Human Genome Project and its revolutionary impact, the book further investigates new technologies in detail, including: high-throughput DNA sequencing, genome sequence databases, microarrays, proteomics, pharmacogenomics, genetic testing, and gene therapy. ... Read more

Reviews (6)

Highly Recommended
"...this book was exactly what I was looking for: a high-level overview of genomic technologies and their application...Brown's book is highly recommended..." (Pharmaceutical Research, Vol. 20, No. 6, June 2003)

Recommended Book
"readable account of the underpinnings of genomics and its medical applications...a clearly written book that makes a complex discipline understandable..." (New England Journal of Medicine, July 24, 2003)

Good Book
"...a good purchase for...academic or medical libraries as well as large public ones." (E-Streams, Vol. 6, No. 5, May 2003)

Useful Book
"It will be quite useful to anyone from other fields who is interested in a taste of what emerging technologies in genomics, proteomics, and bioinformatics can bring to bear on questions of potential importance in biomedical research." --American Journal of Human Genetics

Useful Book
"...useful to both medical students and physicians alike..." (Genomics and Proteomics, March 1, 2003) ... Read more

Book Description

The International Handbook of Research in Medical Education is a review of current research findings and contemporary issues in health sciences education. The orientation is towards research evidence as a basis for informing policy and practice in education. Although most of the research findings have accrued from the study of medical education, the Handbook will be useful to teachers and researchers in all health professions and others concerned with professional education.The Handbook comprises 33 chapters organized into six sections: Research Traditions, Issues in Learning, The Educational Continuum, Instructional Strategies, Assessment, and Implementing the Curriculum. The authors are internationally recognized authorities in medical education, who have all made substantial contributions to this literature.The research orientation of the Handbook makes this work an invaluable resource to researchers and scholars, and should help practitioners to identify research to place their educational decisions on a sound empirical footing. ... Read more

Book Description

From the author of the bestselling "The Man Who Knew Infinity" comes an unprecedented look at the traditional master-apprenticeship relationship alive today in modern science. Along the way, using interviews and anecdotes, Kanigel takes readers into the heady world of a remarkable group of scientists at the National Institutes of Health and Johns Hopkins University and captures the drama of their breakthrough discoveries. ... Read more

Reviews (2)

Scientific excellence is inheritable!
Several years ago, my former mentor circulated this book in the lab. Until quite recently, my friends still found me quoting from it while talking about scientific ideas. Now, after reading the book for many times, and studying the characteristics of great mentors around me, I conclude that it's a marvelous book. Anyone who plan to have a bright scientific career should read this book. My only dissatisfaction is the book is so old. I demand a new edition or a sequel! And, I want more examples of such lineage of excellent scientists as described in the book.Surely, it's book that I will share with my student.

An excellent look at how mentoring in academics works.....
While seemingly on a mundane and complicated subject (pharmacology and its researchers), it is an easy read for any layman and very, very interesting (especially on the topic of malaria medications and their discovery and problems)... Very interesting how hitching your star to the right person can make your career...and how pettiness and back-stabbing can be so cruel and counterproductive... A very, very good read for anyone even remotely interested in science... ... Read more

Book Description

This is the first comprehensive text on the design and analysis of group-randomized trials.It collects information previously scattered among journals and texts in a variety of disciplines, and, in addition, presents much new material not available elsewhere. The book has been written to help those involved in these trials improve their ability to plan, fund, conduct, analyze, and interpret them, and to give students a detailed understanding of the field.

Group-randomized trials are comparative studies in which the units of assignment are identifiable groups and the units of observation are members of those groups. The positive intraclass correlation expected among the members of each group poses unique and challenging issues for the design and analysis of these trials and separates them from the traditional clinical trial. After reviewing the underlying issues, Murray presents the research designs that are most widely used in group-randomized trials, together with their strengths, weaknesses, and appropriate applications. He describes the many approaches to analysis that are now available, presents mixed-model regression analyses appropriate to each design, and illustrates them using data from the Minnesota Heart Health Program. He also covers methods for estimating sample size, detectable difference, and power. This volume is not limited only to a conceptual treatment of the issues and solutions. It offers a review of the practical applications in a series of case studies, examples, and problems. ... Read more

Book Description

The most important concept in statistics is the probability model. Only by fully understanding this model can one fully understand statistical analysis. Utilizing models in epidemiology, the authors of this self-contained account have chosen to emphasize the role of likelihood. This approach to statistics is both simple and intuitively satisfying. More complex problems can be tackled by natural extensions of the simple methods. This exploration of the statistical basis of epidemiology has been written specifically for professionals and graduate students in epidemiology, clinical epidemiology, or biostatistics. The simple prerequisite--basic training in biology--assumes no previous knowledge and the mathematics is deliberately kept at a manageable level. Based on a highly successful course by two internationally known authors, this book explains the essentials of statistics for all epidemiologists. ... Read more

Reviews (2)

Outstanding mongraph for biostatisticians
I find all other so-called biostatistics books are helpless
until I have read this book. This book is written based on
Clayton and Hills's past experience in applying statistics
in their studies. They can illustrate most difficult concepts
by very simple examples and words which are totally differnt
than other text and teaching books. For other books, you
can learn a lot of various statistical techniques, but you
cannot understand what is the core idea behind the statistics.
You may get it from this book.

A very good for the non-Mathematician
Clayton and Hill's book is an excellent introduction to the Statistics underlying epidemiology for readers who are not specialist Mathematicians. The book does explain fairly erudite ideas, but it does so gently and the Mathematics used is elementary. There are also many not-too-hard exercises at the ends of sections, making this a very gopd bok to learn from. Highly recommended. ... Read more

Book Description

This volume and its companion Nonhuman Primates in Biomedical Research: Biology and Management represent the most comprehensive publications of their type on nonhuman primates. This volume addresses the diseases of nonhuman primates with an emphasis on the etiological factors, clinical signs, diagnostic pathology, therapy, and management. Its companion volume serves as a general reference for those who provide care for these animals and for those who use them in biomedical research. ... Read more

Reviews (12)

Readable and timely pieces on the human brain
Kotulak provides the interested layman with a series of short chapters dealing with relatively recent discoveries about how the human brain works, how early experiences affect brain chemistry (and behavior), and what can be done to maintain maximum brain efficiency. It is a fine introduction to the neurobiology of the brain and recent discoveries that will have a lasting impact on how we view human behavior. Chapters are concise and to-the-point and leave the reader with much to ponder. More diagrams and illustrations would have greatly improved the book, but the price is right. I teach an adult course on brain biology, and of all the affordable "brain" books I reviewed this one works out best as a reference source for students in terms of stimulating discussion.

Nice, informative little book.
This book raises some very important issues. It is a popular account of some not-so-modern-anymore research in brain plasticity, development and neurochemistry, as well as some genetics. The main points the author wishes to get across are the fact that the brain is molded by the enviroment, that molecular neurobiology is beginnig to use the brain's plasticity to heal it, and that behavior and personality have strong biological bases. All of these points are corroborated, and the book discusses work done by lots of interviewed neuroscienctists. The text is real easy to understand, and has a lot of valuable information in it. It is by a journalist, and reads like a piece of journalism.
The thing I most dislike about these kinds of books is that thay are too optimistic. Yes, you understood right. ONly one side of the debate is presented. And the research discussed is oversimplified to astonishing degrees. I mean, it is not scienctifically responsible to make claims like "receptor x is for agressiveness, receptor y for attentiveness, receptor z for arousal". Those are gross simplifications. It is simply ridiculous to make such claims. Another thing is that the author fails to mention that almost every research mentioned is contested by some other that failed to get the same results. Genes or receptors for this or that arise every week, are refuted the next week, and brought back to life the next week after that. The field is really promising, but it is also really murky right now.
The discussion on plasticity, new thechniques fighting strokes and Altzheimers, and the importance of enviroment on development are pretty accurate, however. The author does a good job in showing the great impact the change of view from "hard-wired" to "fluid" has had in the neurosciences. This is really some of the most iteresting issues, and those that most easily will have an impact on daily life. But the book is by no means scientifically rigorous.

Section 1: A must for new Parents, Grandparents, and Teacher
Section 1 is presented in an easy, non-technical way that permits any person keen on helping develop the young mind, develop it to its maximum capacity. Research is well documented. Educators should be guided by such presentations in the ways school curricula are designed. The sections on brain injury and healing are a little more technical, but point to a very exciting short term future in addressing neruological problems. The concluding remarks refocus the reader on just how important very early and continuous education is important to us.

A Must for parents, educators, doctors, and politicians
This easy to read, informative book gives a clear picture of how stimuli connects and wires our brains from conception on. How bad stress, substance abuse, and physical abuse can lead to white matter damage. The research and references are outstanding. This book should be mandatory for all educators and parents. Dr. James A McGregor and Suzi McGregor

A positive and useful book about the brain
When this book was first assigned in a college course, I sighed inwardly, imagining long nights filled with tongue twisting neurobabble in my future. So I was happily surprised when I found the writing to be consise, easy-to-read, and above all, interesting. Inside the Brain is written for the non scientist by a non scientist. The theories discussed are riveting. I never had any idea that child rearing before the age of five could have such a positive or negative affect on a child's brain. Or that violence can become hard-wired through the environment a child is raised in. The discussion of addiction and alcoholism is fascinating. I would be very happy if a cure for these deadly and humiliating diseases was found in the near future. Although much of what is presented in the book is grim, Kotulak manages to put a touch of hope into all of the findings. People from all walks of life would benefit from the information found in this book. ... Read more

Book Description

This is the only textbook for medical students and public health school students that combines the disciplines of epidemiology, biostatistics, preventive medicine, and public health in one convenient book.Written by renowned experts in the field, this text presents the information you need with a clinical slant using real-life medical examples throughout.Combining all four disciplines in one book creates an integrated approach that shows the interrelationships among these fields and stresses their clinical relevance. In addition to medical and public health school students, this text serves as a source of information for health care professionals who wish to study these topics on their own or to review for medical board examinations.A comprehensive examination including 350 USMLE-style questions with detailed answers and explanations is provided. This text is recommended by the American Public Health Association as one of the best sources for review for residents preparing for the boards in public health medicine. ... Read more

Reviews (1)

Useful study tool for students of epidemiology
This is a useful study guide and reference tool for anyone who is starting in epidemiology. It gives a great overview on study designs, statistics, and a great deal of other useful information for creating, implementing and evaluating a study. I have found it extremely useful in both my studies and in the implementation of studies. I would recommend this book as a study tool in any epidemiology course! ... Read more

Book Description

The Bayesian approach involves collecting data from past experience in order to reach conclusions about future events. Bayesian methods have become increasingly popular in recent years, notably in medical research. There are a large number of books on Bayesian analysis, but very few that cover clinical trials and biostatistical applications in any capacity. There is no book available that is introductory in nature and covers such a broad array of essential topics. This book provides a valuable overview of this rapidly evolving field, not only for statisticians in the pharmaceutical industry, but also to anyone involved in conducting clinical trials and HTA work. Comprehensive coverage of Bayesian methods in medical research

• Illustrated throughout by case studies and worked examples
• Authors are at the forefront of research into Bayesian methods in medical research
• Suitable for those with a limited statistical background
• Accompanied by a Web site featuring data sets and worked examples in WinBUGS - the most widely accepted Bayesian modelling package

  
  ... Read more

Book Description

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.

• Provides a practical overview of data monitoring in clinical trials.
• Describes the purpose, responsibilities and operation of data monitoring committees.
• Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
• Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
• Discusses issues pertinent to those working in clinical trials in both the US and Europe.

Book Description

This reference series provides researchers of all kinds with comprehensive practical information on different species of laboratory animals, for daily laboratory use. Each title in the series in devoted to a different species. and draws together all available data in one easily accessible source. Each has similar format, with sections on the strains available, their husbandry and special diets. This leads to sections on gross anatomy, endocrinology and reproduction, followed by more detailed sections on neuroanatomy, vasculature, cell biology and histology of particular organs and structures, and a section on molecular biology.
High quality illustrations are included throughout, with copious color histology microphotographs.

Key Features
* Comprehensive reference source for anybody working with laboratory fish
* 2-color, user-friendly format
* Copious high quality illustrations included throughout
* Color plate section
* Glossary
* Appendix of useful addresses ... Read more

Book Description

Investigation of the functional architecture of the human brain using modern noninvasive imaging techniques is a rapidly expanding area of research. A proper knowledge of methodology is needed to appreciate the burgeoning literature in the field. This timely publication provides an excellent catalogue of the main techniques.

The authors offer an invaluable analysis of mapping strategies and techniques, providing everything from the foundations to the major pitfalls and practical applications of the modern techniques used in neuroimaging. Contains over 1000 full color pages with more than 200 color figures.

Spanning the methodological gamut from the molecular level to the whole brain while discussing anatomy, physiology, and pathology, as well as their integration, Brain Mapping: The Methods, 2e, brings the reader a comprehensive, well-illustrated and entirely readable description of the methods for brain mapping. Drs. Toga and Mazziotta provide everything from the foundations to the major pitfalls and practical applications of the technique by assembling an impressive group of experts, all widely known in their field, who contribute an outstanding set of chapters. ... Read more

Book Description

This is a book for statistical practitioners, particularly those who design and analyze studies for survival and event history data. Its goal is to extend the toolkit beyond the basic triad provided by most statistical packages: the Kaplan-Meier estimator, log-rank test, and Cox regression model. Building on recent developments motivated by counting process and martingale theory, it shows the reader how to extend the Cox model to analyze multiple/correlated event data using marginal and random effects (frailty) models. It covers the use of residuals and diagnostic plots to identify influential or outlying observations, assess proportional hazards and examine other aspects of goodness of fit. Other topics include time-dependent covariates and strata, discontinuous intervals of risk, multiple time scales, smoothing and regression splines, and the computation of expected survival curves. A knowledge of counting processes and martingales is not assumed as the early chapters provide an introduction to this area. The focus of the book is on actual data examples, the analysis and interpretation of the results, and computation. The methods are now readily available in SAS and S-Plus and this book gives a hands-on introduction, showing how to implement them in both packages, with worked examples for many data sets. The authors call on their extensive experience and give practical advice, including pitfalls to be avoided. ... Read more

Reviews (3)

One of the best statistics texts available today!
As a biostatistics PhD student I've had to endure many very poorly written textbooks (though there are many good one's too). Not only is this book a great text on applied survival analysis, it's a great piece of statistical writing and should be used as an example for all applied texts. The general approach of introducing the theory followed by examples with SAS/SPlus code makes learning the material easy and fun. I wish all statistics texts were even half this good!

Anderson et al for the common man
This text is one of the few to make the work of Andersen et al. (Statistical Models Based on Counting Processes, Springer, 1993) accessible to the average statistician. It has three limitations:
1) fails to mention the use of permutation tests for hypotheses regarding the Nelson-Aalen estimator,
2) fails to cite Good PI, Globally almost most powerful tests for censored data,Nonpar Statist 1992, 1:253-262.
3) fails to deal with multiple dependent events (the most common case).
The text also fails to be prescriptive; one is often left feeling that all tests are equal which simply isn't the case.

Great coverage of extensions to important models
Terry Therneau is a research statistician at the Mayo Clinic and Patricia Grambsch is a Professor of Biostatistics at the University of Minnesota. The Cox proportional hazards model has been one of the key methods for analyzing survival data with covariates for the last 25 years. Proportionality is a key assumption that limits its use. There has long been a need to find methods which diagnose when the hazard rates are not proportional and provide alternative methods in such situations. Using the theory of counting processes the authors are able to extend the Cox model to more general situations including multiple/correlated event data using either marginal models or random effects (frailty) models. Time dependent covariates are also covered. Some of the theory of martigales and counting processes is included to make the book self-contained. Generalized residuals are used to identify outlying and influential observations (analogous to ordinary regression) and also to assess the proportional hazards assumption.

Although the topics are advanced and the mathematical level is high the book is designed for practitioners, emphasizing applications and providing numerous examples, many from the authors' experience. Statistical analyses are done in SAS and SPlus. The authors tend to use SAS for data management and analysis and SPlus for diagnostics and other plots. Therneau is an expert programmer who has written much of the necessary software in both systems.

Therneau gave an excellent short course that I attended a couple of years ago at the Joint Statistical Meetings based on a draft of the text. The finished product is as good as I expected.

The appendices include SAS and S-Plus tutorials on survival analysis and provide SAS Macros and S functions to apply the new methodology. ... Read more