Statistical Methods in Analytical Chemistry

This new edition of a successful, bestselling book continues to provide you with practical information on the use of statistical methods for solving real-world problems in complex industrial environments. Complete with examples from the chemical and pharmaceutical laboratory and manufacturing areas, this thoroughly updated book clearly demonstrates how to obtain reliable results by choosing the most appropriate experimental design and data evaluation methods. Unlike other books on the subject, Statistical Methods in Analytical Chemistry, Second Edition presents and solves problems in the context of a comprehensive decision-making process under GMP rules: Would you recommend the destruction of a $100,000 batch of product if one of four repeat determinations barely fails the specification limit? How would you prevent this from happening in the first place? Are you sure the calculator you are using is telling the truth? To help you control these situations, the new edition:

• Covers univariate, bivariate, and multivariate data
• Features case studies from the pharmaceutical and chemical industries demonstrating typical problems analysts encounter and the techniques used to solve them
• Offers information on ancillary techniques, including a short introduction to optimization, exploratory data analysis, smoothing and computer simulation, and recapitulation of error propagation
• Boasts numerous Excel files and compiled Visual Basic programs-no statistical table lookups required!
• Uses Monte Carlo simulation to illustrate the variability inherent in statistically indistinguishable data sets Statistical Methods in Analytical Chemistry, Second Edition is an excellent, one-of-a-kind resource for laboratory scientists and engineers and project managers who need to assess data reliability; QC staff, regulators, and customers who want to frame realistic requirements and specifications; as well as educators looking for real-life experiments and advanced students in chemistry and pharmaceutical science. From the reviews of Statistical Methods in Analytical Chemistry, First Edition: “This book is extremely valuable. The authors supply many very useful programs along with their source code. Thus, the user can check the authenticity of the result and gain a greater understanding of the algorithm from the code. It should be on the bookshelf of every analytical chemist.”-Applied Spectroscopy “The authors have compiled an interesting collection of data to illustrate the application of statistical methods . . . including calibrating, setting detection limits, analyzing ANOVA data, analyzing stability data, and determining the influence of error propagation.”-Clinical Chemistry “The examples are taken from a chemical/pharmaceutical environment, but serve as convenient vehicles for the discussion of when to use which test, and how to make sense out of the results. While practical use of statistics is the major concern, it is put into perspective, and the reader is urged to use plausibility checks.”-Journal of Chemical Education “The discussion of univariate statistical tests is one of the more thorough I have seen in this type of book . . . The treatment of linear regression is also thorough, and a complete set of equations for uncertainty in the results is presented . . . The bibliography is extensive and will serve as a valuable resource for those seeking more information on virtually any topic covered in the book.”-Journal of American Chemical Society “This book treats the application of statistics to analytical chemistry in a very practical manner. [It] integrates PC computing power, testing programs, and analytical know-how in the context of good manufacturing practice/good laboratory practice (GMP/GLP) . . .The book is of value in many fields of analytical chemistry and should be available in all relevant libraries.”-Chemometrics and Intelligent Laboratory Systems

Author Biography

PETER C. MEIER, PhD, currently serves as Director for the Cilag A.G., a member of the Johnson & Johnson Company, and as a faculty member for the Swiss Federal Institute of Technology in Zürich (ETH-Z). The author/coauthor of 27 publications, Dr. Meier has held managerial positions in both Quality Assurance and pharmaceutical R&D, sat on the board of the former Swiss Society for Instrumental Analysis, and for many years was a member of Analytica Chimica Acta’s Advisory Board.

RICHARD E. ZÜND, PhD, has been with Teranol A.G., a member of the Roche Group, since 1995 and is currently responsible for Teranol’s IPC/QC/QA section, which covers, among other things, equipment, methods, statistics, audits, and specifications. Dr. Zünd is a member of Roche’s Divisional QA and GMP Expert Team for the Vitamins and Fine Chemicals Sector. He previously headed the QA-IPC section and was strongly involved in ISO 9001 and LIMS projects, among other functions.