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Pharmaceutical Statistics
This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D – with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applicatio...
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...
Technometrics
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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.
AMSTAT News
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Introduction to Genomics
Introduction to Genomics is a fascinating insight into what can be revealed from the study of genomics: how organisms differ or match; how different organisms evolved; how the genome is constructed and how it operates; and what our understanding of genomics means in terms of our future health and wellbeing. Covering the latest techniques that enable us to study the genome in ever-increasing detail, the book explores what the genome tells us about life at the level of the molecule, the cell, and the organism. Learning features throughout make this book the ideal teaching and learning tool: extensive end of chapter exercises and problems help the student to fully grasp the concepts being presented, while end of chapter WebLems (web-based problems) and lab assignments give the student the opportunity to engage with the subject in a hands-on manner.
Variowin
1.1 Overview V ARIOWIN 2.2 is a collection of four WindowsTM programs - Prevar2D, Vari02D with PCF, Model, and Grid Display - that are used for spatial data analysis and variogram modeling of irregularly spaced data in two dimensions. Prevar2D builds a pair comparison file (PCF), that is, a binary file containing pairs of data sorted in terms of increasing distance. Pair comparison files can be built from subsets in order to reduce memory requirements. Vari02D with PCF is used for spatial data analysis of 2D data. It uses an ASCII data file and a binary pair comparison file produced by Prevar2D. Features implemented in Vari02D with PCF include: • the possibility to characterize the spatial...
Reactive Drug Metabolites
Closing a gap in the scientifi c literature, this first comprehensive introduction to the topic is based on current best practice in one of the largest pharmaceutical companies worldwide. The first chapters trace the development of our understanding of drug metabolite toxicity, covering basic concepts and techniques in the process, while the second part details chemical toxicophores that are prone to reactive metabolite formation. This section also reviews the various drug-metabolizing enzymes that can participate in catalyzing reactive metabolite formation, including a discussion of the structure-toxicity relationships for drugs. Two chapters are dedicated to the currently hot topics of her...
Data Driven Statistical Methods
Calculations once prohibitively time-consuming can be completed in microseconds by modern computers. This has resulted in dramatic shifts in emphasis in applied statistics. Not only has it freed us from an obsession with the 5% and 1% significance levels imposed by conventional tables but many exact estimation procedures based on randomization tests are now as easy to carry out as approximations based on normal distribution theory. In a wider context it has facilitated the everyday use of tools such as the bootstrap and robust estimation methods as well as diagnostic tests for pinpointing or for adjusting possible aberrations or contamination that may otherwise be virtually undetectable in c...
