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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R wil...
AMSTAT News
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Current Index to Statistics, Applications, Methods and Theory
The Current Index to Statistics (CIS) is a bibliographic index of publications in statistics, probability, and related fields.
Biotechnology and Ecology of Pollen
In Recognition of the Forgotten Generation D. L. MULCAHyl Pollen was long believed to serve primarily a single function, that of delivering male gametes to the egge A secondary and generally overlooked value of pollen is that it serves to block the transmission of many defective alleles and gene combinations into the next generation. This latter function comes about simply because pollen tubes carrying defective haploid genotypes frequently fail to complete growth through the entire length of the style. However, the beneficial consequences of this pollen selection are diluted by the fact that the same deleterious genotypes are often transmitted through the egg at strictly mendelian frequenci...
Safety, Risk and Adventure in Outdoor Activities
′"Bureaucracy is the reason for the decline in school trips". A statement often quoted. But it is a myth that there is a decline in school visits... It′s competent people, not paperwork, that make visits safer′ - Ian Park, ex-Chairman, Outdoor Education Advisers′ Panel ′Every man and woman who is involved in the development or education of young people - however slightly - should be chained to one of the Barns of Bynack and not released until they have read this book cover to cover′ - Alan Bantick, wildlife conservationist, lecturer, photographer and guide ′Bob Barton′s balanced and well thought out book will help anyone involved with the planning and management of outdoor ac...
Technometrics
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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an inval...
Quality by Design for Biopharmaceutical Drug Product Development
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and...
