Books
Method validation and a whole lot more
Development and Validation of Analytical Methods Christopher M. Riley and Thomas W. Rosanske, Eds. Elsevier Science P.O. Box 945 New York, NY 10160 1996, 352 pp., $88
The editors of this book admit in the introduction that they had intended to consider only the validation of analytical methods, but that they soon realized that method validation is intimately tied to many other issues. Their decision to include these related issues broadens the scope of readership and impresses upon the reader the far-reaching importance of product acceptability, not only to the users of pharmaceuticals and medical devices but also to manufacturers and regulators. The basic concepts of method validation and interlaboratory transfer are discussed in the first chapter, followed by chapters on statistics, the regulatory aspects of validation, and the particular product sectors. The "nuts and bolts" of analytical method validation receive varying amounts of attention in the several chapters related to the product sectors. Although the editors state that the book is not intended to be a practical description of the method validation process, Chapter 10 on bioanalytical samples is just that. For anyone totally unfamiliar with this subfield of the pharmaceutical industry, the chapter provides some guidelines 38 A
that, although valuable, tend to cloud the stated intent of the book with overly specific mandates and examples. A better approach for this chapter might have been to comment on thefindingsof the consensus reports (references 11 and 12 of this chapter) and offer a more general overview of the current guidelines on biological sample method validation. Most of the other chapters provide a good balance between the policy and practice of method validation. The book is a valuable introduction to this important aspect of drug development for analytical scientists new to the pharmaceutical industry; it will also educate veterans who
This book educates both newcomers and veterans to pharmaceutical method development.
A matter of fat
Lipid Analysis F. W. Hemming and J. N. Hawthorne Bios Scientific Publishers 9 Newtec Place, Magdalen Rd. Oxford 0X4 1RE, United Kingdom 1996, 176 pp., $34.95
Lipid Analysis is yet another book on this popular subject. The authors of this book have, however, found a niche in the student or professional new to this field. Practical advice is provided in this well-organized book, beginning with descriptions of basic analytical techniques and the fundamental principles of chromatographic separation methods essential to the lipid chemist. This section is followed by chapters on specific lipid groups, such as phospholipids and glycolipids. The sections on biological signifihave responsibility for limited aspects of product development. The book will bene- cance, structure, detection, isolation and fit regulators who are unaware of develop- purification, and quantitation efficiently provide useful information. ments in analytical technology (especially Chapter 9 on biotechnology products) and The chapter on basic analytical techdata handling (Chapter 12 on computer niques gives a good overview of methods systems and computer-aided validation). commonly used in lipid analysis, although it may falsely imply that paper chromatogThe subject index is thorough for a raphy and GC with packed columns are book of this scope, and many of the refcontemporary analytical methodologies. erences are as recent as 1995.1 recommend this book to any analytical chemist This section of the book would also have provided an excellent but neglected opin the pharmaceutical industry who portunity to elaborate on the usefulness of deals with methodology receiving regusilver ion chromatography as a separation latory scrutiny. Reviewed by Jackson Scholl, Pharmaciamethod based on degree of unsaturation and on the value of the modern evapora& Upjohn
Analytical Chemistry News & Features, January 1, 1997
