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Handbook of Analytical Validation
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Analytical Method Development and Validation
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Prions and Mad Cow Disease
The alarm sounded by Canada's confirmed case of bovine spongiform encephalopathy (BSE) has reaffirmed the exigency of establishing improved safeguards and more aggressive surveillance protocols in North America and around the world. Research converging on the probable causative agent--prion proteins--calls for intensive assessment of the headway gained in tracing prions, testing for transmissible neurodegenerative diseases, and developing methods for cornering the epidemic. With an illustrious panel of 36 international contributors, this timely book marshals techniques for prion protein assay and diagnosis of transmissible spongiform encephalopathies (TSEs).
Capillary Electrophoresis Technology
Tracing the sequence of observations that has led to current understanding in the field, this reference presents the basic concepts, instrumentation and applications of capillary electrophoresis, examining its many features such as high-power resolution, high-mass sensitivity, overall sensitivity and low-sample volume requirements. This work highlights the use of capillary elctrophoresis for the identification, separation, detection and characterization of substances on the molecular counting level. Illustrating the major technical maneuvers for common operations and applications, Capillary Electrophoresis Technology outlines the theoretical concepts and mathematical expressions of capillary...
TRAC: Trends in Analytical Chemistry
Trends in Analytical Chemistry, Volume 4 focuses on the advancements of processes, technologies, operations, automation, and applications of analytical chemistry. The selection first offers information on bullet-proof input with an IBM-PC, including trends in pesticide residue analysis; environmental analysis using gas chromatography; and ion-induced spectroscopic methods for the analysis of surfaces, interfaces, and thin films. The text then elaborates on the PROLOG, an artificial intelligence language, and the consideration of FORTH as a good programming environment for laboratory automation. Discussions focus on computer aided optimization in high performance liquid chromatography; porphy...
Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery
The microfluidic lab-on-a-chip allows scientists to conduct chemical and biochemical analysis in a miniaturized format so small that properties and effects are successfully enhanced, and processes seamlessly integrated. This microscale advantage translates into greater sensitivity, more accurate results, and better information. Microfluidic
